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Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001)

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: NCT03882047
Recruitment Status : Completed
First Posted : March 20, 2019
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rhinitis, Allergic, Seasonal
Interventions Drug: Mometasone furoate
Drug: Fluticasone propionate
Drug: Mometasone furoate placebo
Drug: Fluticasone propionate placebo
Enrollment 313
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days. Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days. Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Period Title: Overall Study
Started 104 105 104
Treated 104 104 103
Completed 98 95 88
Not Completed 6 10 16
Reason Not Completed
Adverse Event             0             2             2
Treatment Failure             3             3             12
Lost to Follow-up             0             1             0
Did Not Wish to Continue             1             4             1
Noncompliance With Protocol             2             0             0
Did Not Meet Eligibility             0             0             1
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray Total
Hide Arm/Group Description Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days. Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days. Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days. Total of all reporting groups
Overall Number of Baseline Participants 104 104 103 311
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 104 participants 103 participants 311 participants
31.72  (10.61) 30.88  (10.71) 31.14  (11.62) 31.25  (10.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 103 participants 311 participants
Female
49
  47.1%
53
  51.0%
39
  37.9%
141
  45.3%
Male
55
  52.9%
51
  49.0%
64
  62.1%
170
  54.7%
1.Primary Outcome
Title Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)
Hide Description Change from baseline averaged over study Day 1 through study Day 15 was calculated for Total Nasal Symptom Score, based on participant diaries. Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in their diaries using the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The Total Nasal Symptom Score was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) Change from baseline was the 15-day average score minus the baseline score. Scores were recorded twice daily, in the morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. Baseline score was an average of the 3 AM scores and 3 PM scores preceding treatment. Negative changes indicated a decrease in symptom severity.
Time Frame Baseline and Day 1 through Day 15 (averaged over 15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least one valid post-baseline visit and had available diary data.
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Overall Number of Participants Analyzed 104 104 103
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-2.8  (2.2) -3.4  (2.3) -0.9  (2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Nasal Spray, Fluticasone Propionate Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation)
Hide Description Change from baseline at Day 4 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score – baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Time Frame Baseline (Day 1) and Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least one valid post-baseline visit and had available Day 4 visit data for Total Nasal Symptom Score.
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Overall Number of Participants Analyzed 103 104 103
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-3.2  (2.8) -3.5  (3.0) -1.8  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Nasal Spray, Fluticasone Propionate Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation)
Hide Description Change from baseline at Day 15 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score – baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Time Frame Baseline (Day 1) and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least one valid post-baseline visit and had available Day 15 visit data for Total Nasal Symptom Score.
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Overall Number of Participants Analyzed 95 95 88
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-4.4  (2.9) -5.5  (2.7) -2.7  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Nasal Spray, Fluticasone Propionate Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
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 Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation)
Hide Description Change from baseline at Day 4 was calculated for the Overall Condition of Seasonal Allergic Rhinitis, as assessed by the physician. The physician scored their overall condition on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score – baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Time Frame Baseline (Day 1) and Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Overall Condition of Seasonal Allergic Rhinitis (physician evaluated).
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Overall Number of Participants Analyzed 103 104 103
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-0.5  (0.7) -0.7  (0.8) -0.3  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Nasal Spray, Fluticasone Propionate Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation)
Hide Description Change from baseline at Day 15 was calculated for the overall condition of seasonal allergic rhinitis, as assessed by the physician. The physician scored their overall condition on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score – baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Time Frame Baseline (Day 1) and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Overall Condition of Seasonal Allergic Rhinitis (physician evaluated)
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Overall Number of Participants Analyzed 95 95 88
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-0.9  (0.8) -1.2  (0.8) -0.5  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Nasal Spray, Fluticasone Propionate Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
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 Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation)
Hide Description The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 4, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score – baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Time Frame Baseline (Day 1) and Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Overall Condition of Seasonal Allergic Rhinitis (participant evaluation).
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Overall Number of Participants Analyzed 103 104 103
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-0.6  (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 Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Nasal Spray, Fluticasone Propionate Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation)
Hide Description The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 15, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score – baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Time Frame Baseline (Day 1) and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Overall Condition of Seasonal Allergic Rhinitis (participant evaluation)
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Overall Number of Participants Analyzed 95 95 88
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-1.1  (0.8) -1.3  (0.8) -0.5  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Nasal Spray, Fluticasone Propionate Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Response to Therapy at Day 4 (Physician Evaluation)
Hide Description Response to therapy was assessed by evaluating the participant’s relief of nasal symptoms at Day 4. The physician evaluated the participant's response using the following 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Response to Therapy (physician evaluation).
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Overall Number of Participants Analyzed 103 104 103
Mean (Standard Deviation)
Unit of Measure: Score on a scale
3.2  (0.9) 3.1  (1.1) 3.8  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Nasal Spray, Fluticasone Propionate Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Response to Therapy at Day 15 (Physician Evaluation)
Hide Description Response to therapy was assessed by evaluating the participant’s relief of nasal symptoms at Day 15. The physician evaluated the participant's response using the following 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Response to Therapy (physician evaluation).
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Overall Number of Participants Analyzed 95 95 88
Mean (Standard Deviation)
Unit of Measure: Score on a scale
2.7  (1.1) 2.4  (1.1) 3.2  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Nasal Spray, Fluticasone Propionate Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
10.Secondary Outcome
Title Response to Therapy at Day 4 (Participant Evaluation)
Hide Description Response to therapy was evaluated by participants and based upon their status scored at Day 4. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Response to Therapy (participant evaluation).
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Overall Number of Participants Analyzed 103 104 103
Mean (Standard Deviation)
Unit of Measure: Score on a scale
3.2  (0.9) 3.1  (1.1) 3.7  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Nasal Spray, Fluticasone Propionate Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
11.Secondary Outcome
Title Response to Therapy at Day 15 (Participant Evaluation)
Hide Description Response to therapy was evaluated by participants and based upon their status scored at Day 15. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Response to Therapy (participant evaluation).
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Overall Number of Participants Analyzed 95 95 88
Mean (Standard Deviation)
Unit of Measure: Score on a scale
2.6  (1.1) 2.4  (1.1) 3.4  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
Comments [Not Specified]
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 Nasal Spray, Fluticasone Propionate Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Up to 45 days
Adverse Event Reporting Description All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.
 
Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days. Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days. Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
All-Cause Mortality
Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/104 (0.00%)      0/104 (0.00%)      0/103 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/104 (0.00%)      0/104 (0.00%)      0/103 (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 Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/104 (28.85%)      24/104 (23.08%)      28/103 (27.18%)    
General disorders       
FATIGUE  1  1/104 (0.96%)  1 4/104 (3.85%)  5 6/103 (5.83%)  13
Nervous system disorders       
HEADACHE  1  14/104 (13.46%)  19 13/104 (12.50%)  23 18/103 (17.48%)  28
Respiratory, thoracic and mediastinal disorders       
COUGH  1  7/104 (6.73%)  12 7/104 (6.73%)  9 4/103 (3.88%)  6
NASAL DISCOMFORT  1  7/104 (6.73%)  14 6/104 (5.77%)  16 4/103 (3.88%)  8
OROPHARYNGEAL PAIN  1  6/104 (5.77%)  9 2/104 (1.92%)  3 4/103 (3.88%)  7
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: NCT03882047     History of Changes
Other Study ID Numbers: I94-001
I94-001 ( Other Identifier: Schering-Plough Protocol Number )
First Submitted: March 18, 2019
First Posted: March 20, 2019
Results First Submitted: July 24, 2019
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019