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Safety and Efficacy of Mometasone Furoate (SCH 032088) vs Beclomethasone Dipropionate or Placebo in Seasonal Allergic Rhinitis (C93-013)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03855189
Recruitment Status : Completed
First Posted : February 26, 2019
Results First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Seasonal Allergic Rhinitis
Interventions Drug: Mometasone Furoate (MF)
Drug: Beclomethasone Dipropionate (BDP)
Drug: Placebo
Enrollment 345
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days. Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days. Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Period Title: Overall Study
Started 113 116 116
Treated 112 [1] 116 116
Completed 103 109 110
Not Completed 10 7 6
Reason Not Completed
Adverse Event             5             2             4
Treatment Failure             1             1             2
Noncompliance with Protocol             0             1             0
Did Not Return             4             3             0
[1]
Does not include 1 participant who received first dose but was excluded from safety analysis.
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo Total
Hide Arm/Group Description Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days. Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days. Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days. Total of all reporting groups
Overall Number of Baseline Participants 113 116 116 345
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 116 participants 116 participants 345 participants
34.8  (12.3) 34.6  (12.1) 35.5  (11.2) 34.9  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 116 participants 116 participants 345 participants
Female
52
  46.0%
52
  44.8%
72
  62.1%
176
  51.0%
Male
61
  54.0%
64
  55.2%
44
  37.9%
169
  49.0%
1.Primary Outcome
Title Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated)
Hide Description TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching, as rated in their diary in the morning (AM) and evening (PM). The 4 individual symptom scores rated as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For the 15 day interval, participant individual daily scores were totaled and averaged over interval (AM and PM computed separately then averaged) and used to calculate the overall average change from Baseline. Participant average changes were then used to calculate the mean change for each arm for the interval. Average change from Baseline for Days 1-15 = average post-treatment score (Days 1-15) – Baseline average score (average of the Baseline AM/PM diary scores from 3 consecutive days prior to Baseline visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline, and Days 1 through 15 (average of 15 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available diary data.
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 7.6  (2.2) 7.3  (2.2) 7.6  (2.0)
Change from Baseline Days 1-15 -2.3  (2.7) -2.8  (2.1) -1.5  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from ANOVA.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from ANOVA.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Who Experienced ≥1 Adverse Event
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor’s product was also an AE. The number of participants with at least one AE was reported for each treatment group.
Time Frame Up to 31 Days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 112 116 116
Measure Type: Count of Participants
Unit of Measure: Participants
60
  53.6%
64
  55.2%
78
  67.2%
3.Primary Outcome
Title Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor’s product was also an AE. The number of participants who discontinued due to an AE was reported for each treatment group.
Time Frame Up to 31 Days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 112 116 116
Measure Type: Count of Participants
Unit of Measure: Participants
5
   4.5%
2
   1.7%
4
   3.4%
4.Secondary Outcome
Title Change From Baseline in the TNSS At Day 4 (Physician-Evaluated)
Hide Description TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for TNSS.
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
8.3  (1.7) 7.9  (1.7) 8.4  (1.6)
Change From Baseline Day 4 Number Analyzed 110 participants 113 participants 116 participants
-2.4  (2.8) -2.7  (2.2) -1.8  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in the TNSS At Day 8 (Physician-Evaluated)
Hide Description TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for TNSS.
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
8.3  (1.7) 7.9  (1.7) 8.4  (1.6)
Change From Baseline Day 8 Number Analyzed 110 participants 113 participants 113 participants
-3.3  (2.9) -3.8  (2.3) -1.9  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the TNSS At Day 15 (Physician-Evaluated)
Hide Description TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for TNSS.
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
8.3  (1.7) 7.9  (1.7) 8.4  (1.6)
Change From Baseline Day 15 Number Analyzed 107 participants 111 participants 112 participants
-3.3  (2.9) -3.8  (2.7) -2.6  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the TNSS At Day 22 (Physician-Evaluated)
Hide Description TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for TNSS.
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
8.3  (1.7) 7.9  (1.7) 8.4  (1.6)
Change From Baseline Day 22 Number Analyzed 105 participants 110 participants 109 participants
-3.9  (2.9) -4.0  (2.7) -3.2  (2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the TNSS At Day 29 (Physician-Evaluated)
Hide Description TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for TNSS.
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
8.3  (1.7) 7.9  (1.7) 8.4  (1.6)
Change From Baseline Day 29 Number Analyzed 100 participants 105 participants 105 participants
-4.1  (2.9) -4.6  (2.6) -3.2  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated)
Hide Description Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for SAR overall condition (physician-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
2.3  (0.5) 2.2  (0.4) 2.2  (0.1)
Change From Baseline Day 4 Number Analyzed 110 participants 113 participants 116 participants
-0.6  (0.7) -0.5  (0.7) -0.3  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated)
Hide Description Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for SAR overall condition (physician-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
2.3  (0.5) 2.2  (0.4) 2.2  (0.1)
Change From Baseline Day 8 Number Analyzed 110 participants 113 participants 113 participants
-0.7  (0.8) -0.8  (0.7) -0.3  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated)
Hide Description Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for SAR overall condition (physician-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
2.3  (0.5) 2.2  (0.4) 2.2  (0.1)
Change From Baseline Day 15 Number Analyzed 107 participants 111 participants 112 participants
-0.7  (0.8) -0.8  (0.7) -0.5  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated)
Hide Description Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for SAR overall condition (physician-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
2.3  (0.5) 2.2  (0.4) 2.2  (0.1)
Change From Baseline Day 22 Number Analyzed 105 participants 110 participants 109 participants
-0.9  (0.8) -0.8  (0.7) -0.6  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated)
Hide Description Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for SAR overall condition (physician-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
2.3  (0.5) 2.2  (0.4) 2.2  (0.1)
Change From Baseline Day 29 Number Analyzed 100 participants 105 participants 105 participants
-0.9  (0.9) -0.9  (0.8) -0.6  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated)
Hide Description Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for SAR overall condition (participant-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
2.2  (0.5) 2.2  (0.5) 2.3  (0.5)
Change From Baseline Day 4 Number Analyzed 110 participants 113 participants 116 participants
-0.6  (0.8) -0.6  (0.6) -0.4  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated)
Hide Description Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for SAR overall condition (participant-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
2.2  (0.5) 2.2  (0.5) 2.3  (0.5)
Change From Baseline Day 8 Number Analyzed 110 participants 113 participants 112 participants
-0.7  (0.8) -0.8  (0.7) -0.4  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated)
Hide Description Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for SAR overall condition (participant-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
2.2  (0.5) 2.2  (0.5) 2.3  (0.5)
Change From Baseline Day 15 Number Analyzed 107 participants 111 participants 112 participants
-0.7  (0.8) -0.8  (0.8) -0.5  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated)
Hide Description Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for SAR overall condition (participant-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
2.2  (0.5) 2.2  (0.5) 2.3  (0.5)
Change From Baseline Day 22 Number Analyzed 105 participants 110 participants 109 participants
-0.9  (0.8) -0.9  (0.8) -0.7  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated)
Hide Description Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score – Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time Frame Baseline (Day 1), Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for SAR overall condition (participant-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 111 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 111 participants 113 participants 116 participants
2.2  (0.5) 2.2  (0.5) 2.3  (0.5)
Change From Baseline Day 29 Number Analyzed 100 participants 105 participants 104 participants
-0.9  (0.9) -0.9  (0.7) -0.6  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
19.Secondary Outcome
Title Response To Therapy At Day 4 (Physician-Evaluated)
Hide Description Response to therapy was evaluated by the physician and based upon the participant’s status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for response (physician-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 110 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.3  (1.2) 3.2  (1.1) 3.5  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
20.Secondary Outcome
Title Response To Therapy At Day 8 (Physician-Evaluated)
Hide Description Response to therapy was evaluated by the physician and based upon the participant’s status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for response (physician-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 110 113 113
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.0  (1.2) 2.7  (1.1) 3.5  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
21.Secondary Outcome
Title Response To Therapy At Day 15 (Physician-Evaluated)
Hide Description Response to therapy was evaluated by the physician and based upon the participant’s status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for response (physician-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 107 111 112
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.0  (1.1) 2.8  (1.0) 3.3  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
22.Secondary Outcome
Title Response To Therapy At Day 22 (Physician-Evaluated)
Hide Description Response to therapy was evaluated by the physician and based upon the participant’s status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for response (physician-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 105 110 109
Mean (Standard Deviation)
Unit of Measure: scores on a scale
2.8  (1.1) 2.7  (1.1) 3.1  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
23.Secondary Outcome
Title Response To Therapy At Day 29 (Physician-Evaluated)
Hide Description Response to therapy was evaluated by the physician and based upon the participant’s status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for response (physician-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 100 105 105
Mean (Standard Deviation)
Unit of Measure: scores on a scale
2.9  (1.2) 2.5  (1.2) 3.2  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
24.Secondary Outcome
Title Response To Therapy At Day 4 (Participant-Evaluated)
Hide Description Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for response (participant-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 110 113 116
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.3  (1.0) 3.2  (0.9) 3.6  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
25.Secondary Outcome
Title Response To Therapy At Day 8 (Participant-Evaluated)
Hide Description Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for response (participant-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 110 113 113
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.0  (1.0) 2.7  (1.0) 3.5  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
26.Secondary Outcome
Title Response To Therapy At Day 15 (Participant-Evaluated)
Hide Description Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for response (participant-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 107 111 112
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.0  (1.1) 2.7  (0.9) 3.3  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
27.Secondary Outcome
Title Response To Therapy At Day 22 (Participant-Evaluated)
Hide Description Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for response (participant-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 105 110 109
Mean (Standard Deviation)
Unit of Measure: scores on a scale
2.9  (1.1) 2.7  (1.1) 3.1  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
28.Secondary Outcome
Title Response To Therapy At Day 29 (Participant-Evaluated)
Hide Description Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for response (participant-evaluated).
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description:
Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.
Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.
Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Number of Participants Analyzed 100 105 104
Mean (Standard Deviation)
Unit of Measure: scores on a scale
2.9  (1.1) 2.6  (1.1) 3.3  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beclomethasone Dipropionate (BDP), Placebo
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate (MF), Beclomethasone Dipropionate (BDP)
Comments Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Up to 31 Days
Adverse Event Reporting Description All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.
 
Arm/Group Title Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Hide Arm/Group Description Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days. Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days. Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
All-Cause Mortality
Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/112 (0.00%)      0/116 (0.00%)      0/116 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/112 (0.00%)      0/116 (0.00%)      0/116 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mometasone Furoate (MF) Beclomethasone Dipropionate (BDP) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/112 (41.96%)      38/116 (32.76%)      53/116 (45.69%)    
Infections and infestations       
NASOPHARYNGITIS  1  4/112 (3.57%)  4 3/116 (2.59%)  6 6/116 (5.17%)  13
Nervous system disorders       
HEADACHE  1  29/112 (25.89%)  59 27/116 (23.28%)  49 30/116 (25.86%)  66
SINUS HEADACHE  1  11/112 (9.82%)  14 6/116 (5.17%)  8 6/116 (5.17%)  10
Respiratory, thoracic and mediastinal disorders       
NASAL DISCOMFORT  1  4/112 (3.57%)  8 6/116 (5.17%)  15 12/116 (10.34%)  28
OROPHARYNGEAL PAIN  1  7/112 (6.25%)  14 6/116 (5.17%)  11 6/116 (5.17%)  9
SNEEZING  1  0/112 (0.00%)  0 1/116 (0.86%)  2 8/116 (6.90%)  23
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
AE Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 12.0.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor has 30 days prior to submission for publication or presentation to review copies of abstracts or manuscripts for publication (including texts of oral presentations) which report any results of the Protocol study. Sponsor shall have editorial rights with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to proprietary information and the accuracy of the information contained in the publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03855189     History of Changes
Other Study ID Numbers: C93-013
C93-013 ( Other Identifier: Merck )
First Submitted: February 25, 2019
First Posted: February 26, 2019
Results First Submitted: June 21, 2019
Results First Posted: August 9, 2019
Last Update Posted: August 9, 2019