Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)

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: NCT03879772
Recruitment Status : Completed
First Posted : March 19, 2019
Results First Posted : August 12, 2019
Last Update Posted : August 12, 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 Rhinitis, Allergic, Seasonal
Interventions Drug: Mometasone furoate nasal spray
Drug: Beclomethasone dipropionate nasal spray
Drug: Placebo nasal spray
Drug: Chlorpheniramine maleate syrup
Enrollment 679
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MFNS 25 mcg QD MFNS 100 mcg QD MFNS 200 mcg QD BDP 84 mcg BID Placebo
Hide Arm/Group Description Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Period Title: Overall Study
Started 137 135 133 138 136
Completed 133 132 123 130 128
Not Completed 4 3 10 8 8
Reason Not Completed
Adverse Event             2             2             3             4             3
Treatment Failure             1             0             0             2             1
Lost to Follow-up             0             0             0             0             1
Withdrawal by Subject             0             1             3             1             1
Protocol Violation             0             0             3             1             2
Did Not Meet Entry Requirements             1             0             1             0             0
Arm/Group Title MFNS 25 mcg QD MFNS 100 mcg QD MFNS 200 mcg QD BDP 84 mcg BID Placebo Total
Hide Arm/Group Description Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. Total of all reporting groups
Overall Number of Baseline Participants 137 135 133 138 136 679
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 137 participants 135 participants 133 participants 138 participants 136 participants 679 participants
8.8  (1.5) 8.7  (1.6) 8.8  (1.6) 8.7  (1.6) 8.8  (1.6) 8.8  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 135 participants 133 participants 138 participants 136 participants 679 participants
Female
52
  38.0%
51
  37.8%
54
  40.6%
51
  37.0%
52
  38.2%
260
  38.3%
Male
85
  62.0%
84
  62.2%
79
  59.4%
87
  63.0%
84
  61.8%
419
  61.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 135 participants 133 participants 138 participants 136 participants 679 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
   8.0%
11
   8.1%
8
   6.0%
8
   5.8%
11
   8.1%
49
   7.2%
White
114
  83.2%
111
  82.2%
112
  84.2%
119
  86.2%
113
  83.1%
569
  83.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
12
   8.8%
13
   9.6%
13
   9.8%
11
   8.0%
12
   8.8%
61
   9.0%
1.Primary Outcome
Title Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator
Hide Description The mean change from baseline at study day 8 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal 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 indicate a decrease in symptom severity.
Time Frame Baseline (Day 1) and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 8 visit data for TNSS.
Arm/Group Title MFNS 25 mcg QD MFNS 100 mcg QD MFNS 200 mcg QD BDP 84 mcg BID Placebo
Hide Arm/Group Description:
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Overall Number of Participants Analyzed 137 135 132 136 134
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 137 participants 135 participants 132 participants 136 participants 134 participants
7.8  (1.7) 8.1  (1.7) 7.9  (1.6) 8.0  (1.7) 8.0  (1.5)
Change From Baseline Day 8 Number Analyzed 133 participants 134 participants 127 participants 134 participants 130 participants
-2.8  (2.6) -2.8  (2.6) -2.8  (2.5) -2.8  (2.4) -1.9  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, MFNS 100 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way analysis of variance (ANOVA).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, MFNS 200 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, MFNS 200 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection MFNS 200 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection MFNS 200 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BDP 84 mcg BID, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator
Hide Description The mean change from baseline at study day 4 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal 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 indicate a decrease in symptom severity.
Time Frame Baseline (Day 1) and Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 4 visit data for TNSS.
Arm/Group Title MFNS 25 mcg QD MFNS 100 mcg QD MFNS 200 mcg QD BDP 84 mcg BID Placebo
Hide Arm/Group Description:
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Overall Number of Participants Analyzed 137 135 132 136 134
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 137 participants 135 participants 132 participants 136 participants 134 participants
7.8  (1.7) 8.1  (1.7) 7.9  (1.6) 8.0  (1.7) 8.0  (1.5)
Change From Baseline Day 4 Number Analyzed 135 participants 128 participants 128 participants 131 participants 130 participants
-2.2  (2.4) -2.0  (2.1) -2.0  (2.5) -2.4  (2.3) -1.3  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, MFNS 100 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, MFNS 200 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, MFNS 200 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection MFNS 200 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection MFNS 200 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BDP 84 mcg BID, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator
Hide Description The mean change from baseline at study day 15 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal 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 indicate a decrease in symptom severity.
Time Frame Baseline (Day 1) and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 15 visit data for TNSS.
Arm/Group Title MFNS 25 mcg QD MFNS 100 mcg QD MFNS 200 mcg QD BDP 84 mcg BID Placebo
Hide Arm/Group Description:
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Overall Number of Participants Analyzed 137 135 132 136 134
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 137 participants 135 participants 132 participants 136 participants 134 participants
7.8  (1.7) 8.1  (1.7) 7.9  (1.6) 8.0  (1.7) 8.0  (1.5)
Change From Baseline Day 15 Number Analyzed 129 participants 133 participants 123 participants 127 participants 128 participants
-2.9  (2.7) -3.0  (2.8) -3.1  (2.7) -3.5  (2.8) -2.4  (2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, MFNS 100 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, MFNS 200 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, MFNS 200 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection MFNS 200 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection MFNS 200 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BDP 84 mcg BID, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator
Hide Description The mean change from baseline at study day 29 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal 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 indicate a decrease in symptom severity.
Time Frame Baseline (Day 1) and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 29 visit data for TNSS.
Arm/Group Title MFNS 25 mcg QD MFNS 100 mcg QD MFNS 200 mcg QD BDP 84 mcg BID Placebo
Hide Arm/Group Description:
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Overall Number of Participants Analyzed 137 135 132 136 134
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 137 participants 135 participants 132 participants 136 participants 134 participants
7.8  (1.7) 8.1  (1.7) 7.9  (1.6) 8.0  (1.7) 8.0  (1.5)
Change From Baseline Day 29 Number Analyzed 122 participants 127 participants 115 participants 119 participants 120 participants
-3.1  (2.9) -3.7  (2.8) -3.8  (2.6) -3.7  (3.0) -2.5  (2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, MFNS 100 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
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 MFNS 25 mcg QD, MFNS 200 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, MFNS 200 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection MFNS 200 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection MFNS 200 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BDP 84 mcg BID, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary 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 as Assessed by Participant
Hide Description Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.
Time Frame Baseline and Days 1 through 15 (average over 15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available diary data.
Arm/Group Title MFNS 25 mcg QD MFNS 100 mcg QD MFNS 200 mcg QD BDP 84 mcg BID Placebo
Hide Arm/Group Description:
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Overall Number of Participants Analyzed 137 134 133 137 134
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 6.3  (2.3) 6.9  (2.4) 6.9  (2.4) 6.6  (2.4) 6.8  (2.5)
Change From Baseline Days 1 to 15 -1.5  (2.1) -1.9  (2.0) -1.8  (2.1) -1.9  (2.1) -1.2  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, MFNS 100 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, MFNS 200 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, MFNS 200 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection MFNS 200 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection MFNS 200 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BDP 84 mcg BID, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant
Hide Description Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.
Time Frame Baseline and Days 16 through 29 (average over 15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available diary data.
Arm/Group Title MFNS 25 mcg QD MFNS 100 mcg QD MFNS 200 mcg QD BDP 84 mcg BID Placebo
Hide Arm/Group Description:
Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Overall Number of Participants Analyzed 137 134 133 137 134
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline Number Analyzed 137 participants 134 participants 133 participants 137 participants 134 participants
6.3  (2.3) 6.9  (2.4) 6.9  (2.4) 6.6  (2.4) 6.8  (2.5)
Change From Baseline Days 16 to 29 Number Analyzed 134 participants 131 participants 127 participants 135 participants 130 participants
-2.1  (2.6) -2.8  (2.8) -2.7  (2.7) -2.6  (2.8) -1.7  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, MFNS 100 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
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 MFNS 25 mcg QD, MFNS 200 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 25 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, MFNS 200 mcg QD
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection MFNS 100 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection MFNS 200 mcg QD, BDP 84 mcg BID
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection MFNS 200 mcg QD, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection BDP 84 mcg BID, Placebo
Comments Pairwise comparisons were performed using least square means from two-way ANOVA.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MFNS 25 mcg QD MFNS 100 mcg QD MFNS 200 mcg QD BDP 84 mcg BID Placebo
Hide Arm/Group Description Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
All-Cause Mortality
MFNS 25 mcg QD MFNS 100 mcg QD MFNS 200 mcg QD BDP 84 mcg BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/137 (0.00%)      0/135 (0.00%)      0/133 (0.00%)      0/138 (0.00%)      0/136 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
MFNS 25 mcg QD MFNS 100 mcg QD MFNS 200 mcg QD BDP 84 mcg BID Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/137 (0.73%)      0/135 (0.00%)      1/133 (0.75%)      0/138 (0.00%)      0/136 (0.00%)    
Ear and labyrinth disorders           
Ear pain  1  0/137 (0.00%)  0 0/135 (0.00%)  0 1/133 (0.75%)  1 0/138 (0.00%)  0 0/136 (0.00%)  0
Gastrointestinal disorders           
Vomiting  1  0/137 (0.00%)  0 0/135 (0.00%)  0 1/133 (0.75%)  1 0/138 (0.00%)  0 0/136 (0.00%)  0
General disorders           
Pyrexia  1  0/137 (0.00%)  0 0/135 (0.00%)  0 1/133 (0.75%)  1 0/138 (0.00%)  0 0/136 (0.00%)  0
Infections and infestations           
Sinusitis  1  0/137 (0.00%)  0 0/135 (0.00%)  0 1/133 (0.75%)  1 0/138 (0.00%)  0 0/136 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Pathological fracture  1  1/137 (0.73%)  1 0/135 (0.00%)  0 0/133 (0.00%)  0 0/138 (0.00%)  0 0/136 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MFNS 25 mcg QD MFNS 100 mcg QD MFNS 200 mcg QD BDP 84 mcg BID Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/137 (45.26%)      62/135 (45.93%)      58/133 (43.61%)      59/138 (42.75%)      64/136 (47.06%)    
Gastrointestinal disorders           
Abdominal pain upper  1  5/137 (3.65%)  5 4/135 (2.96%)  4 3/133 (2.26%)  5 8/138 (5.80%)  8 2/136 (1.47%)  3
Nausea  1  7/137 (5.11%)  13 1/135 (0.74%)  1 2/133 (1.50%)  2 3/138 (2.17%)  3 2/136 (1.47%)  2
Vomiting  1  3/137 (2.19%)  3 7/135 (5.19%)  7 3/133 (2.26%)  3 5/138 (3.62%)  6 4/136 (2.94%)  4
General disorders           
Pyrexia  1  7/137 (5.11%)  7 8/135 (5.93%)  8 11/133 (8.27%)  13 10/138 (7.25%)  11 11/136 (8.09%)  11
Nervous system disorders           
Headache  1  25/137 (18.25%)  44 27/135 (20.00%)  51 22/133 (16.54%)  28 36/138 (26.09%)  69 24/136 (17.65%)  34
Respiratory, thoracic and mediastinal disorders           
Asthma  1  12/137 (8.76%)  23 10/135 (7.41%)  28 10/133 (7.52%)  15 8/138 (5.80%)  14 17/136 (12.50%)  26
Cough  1  9/137 (6.57%)  11 7/135 (5.19%)  11 18/133 (13.53%)  24 11/138 (7.97%)  18 10/136 (7.35%)  17
Epistaxis  1  14/137 (10.22%)  19 12/135 (8.89%)  20 6/133 (4.51%)  8 6/138 (4.35%)  10 10/136 (7.35%)  12
Oropharyngeal pain  1  10/137 (7.30%)  11 6/135 (4.44%)  7 11/133 (8.27%)  14 10/138 (7.25%)  18 12/136 (8.82%)  15
Sneezing  1  7/137 (5.11%)  11 4/135 (2.96%)  4 0/133 (0.00%)  0 2/138 (1.45%)  4 7/136 (5.15%)  8
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Adverse Event (AE) Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 21.1.
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.
The Principal Investigator agrees not to publish or publicly present any interim results of the Protocol study without the prior written consent of the Sponsor. The Principal Investigator further agrees to provide thirty (30) days prior to submission for publication or presentation to the Sponsor to review copies of abstracts or manuscripts for publication (including texts of oral presentations) which report any results of the Protocol study.
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: NCT03879772     History of Changes
Other Study ID Numbers: C95-161
C95-161 ( Other Identifier: Schering-Plough Protocol Number )
First Submitted: March 15, 2019
First Posted: March 19, 2019
Results First Submitted: June 27, 2019
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019