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

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT03882047
Collaborator
(none)
313
3
1.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of mometasone furoate (SCH 32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment of participants with seasonal allergic rhinitis. Flonase (fluticasone propionate) nasal spray 200 mcg once daily has been chosen as the active control for this study.

Condition or Disease Intervention/Treatment Phase
  • Drug: Mometasone furoate
  • Drug: Fluticasone propionate
  • Drug: Mometasone furoate placebo
  • Drug: Fluticasone propionate placebo
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
313 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Both participant and investigator were blinded to treatment identity. Because the mometasone furoate and fluticasone propionate bottles were not identical in appearance, a double-dummy study design was used and each bottle had a matching placebo. Thus, although participants received bottles of different appearance, they did not know whether bottles contained active substance or placebo.
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Mometasone Furoate Aqueous Nasal Spray vs Placebo and Flonase® (Fluticasone Propionate) in Seasonal Allergic Rhinitis Patients (I94-001)
Actual Study Start Date :
Aug 11, 1994
Actual Primary Completion Date :
Sep 16, 1994
Actual Study Completion Date :
Sep 16, 1994

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mometasone furoate nasal spray

Participants receive 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily.

Drug: Mometasone furoate
Mometasone furoate nasal spray, 200 mg once daily
Other Names:
  • NASONEX®
  • MK-0887
  • SCH 032088
  • Drug: Fluticasone propionate placebo
    Fluticasone propionate placebo matching nasal spray, once daily

    Active Comparator: Fluticasone propionate nasal spray

    Participants receive 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily.

    Drug: Fluticasone propionate
    Fluticasone propionate nasal spray, 200 mg once daily
    Other Names:
  • FLONASE®
  • Drug: Mometasone furoate placebo
    Mometasone furoate placebo matching nasal spray, once daily

    Placebo Comparator: Placebo nasal spray

    Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily.

    Drug: Mometasone furoate placebo
    Mometasone furoate placebo matching nasal spray, once daily

    Drug: Fluticasone propionate placebo
    Fluticasone propionate placebo matching nasal spray, once daily

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries) [Baseline and Day 1 through Day 15 (averaged over 15 days)]

      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.

    Secondary Outcome Measures

    1. Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation) [Baseline (Day 1) and Day 4]

      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.

    2. Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation) [Baseline (Day 1) and Day 15]

      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.

    3. Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation) [Baseline (Day 1) and Day 4]

      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.

    4. Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation) [Baseline (Day 1) and Day 15]

      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.

    5. Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation) [Baseline (Day 1) and Day 4]

      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.

    6. Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation) [Baseline (Day 1) and Day 15]

      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.

    7. Response to Therapy at Day 4 (Physician Evaluation) [Day 4]

      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.

    8. Response to Therapy at Day 15 (Physician Evaluation) [Day 15]

      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.

    9. Response to Therapy at Day 4 (Participant Evaluation) [Day 4]

      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.

    10. Response to Therapy at Day 15 (Participant Evaluation) [Day 15]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 2-year history of seasonal allergic rhinitis

    • Positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)

    • Good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

    Exclusion Criteria:
    • Women who are pregnant or breastfeeding

    • Women of childbearing potential who are not using an acceptable form of birth control

    • Significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study

    • Use of any chronic medication which could affect the course of seasonal allergic rhinitis

    • Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment)

    • Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip

    • Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection (URI) within the 7 days prior to Screening

    • Dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator

    • Has rhinitis medicamentosa

    • Investigational drug use within the previous 30 days

    • Nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow

    • Immunotherapy (desensitization therapy), unless on a stable maintenance schedule for at least one month prior to the Screening visit

    • History of multiple drug allergies, allergy to antihistamines or corticoids

    • History of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT03882047
    Other Study ID Numbers:
    • I94-001
    • I94-001
    First Posted:
    Mar 20, 2019
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    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

    Baseline Characteristics

    Arm/Group Title Mometasone Furoate Nasal Spray Fluticasone Propionate Nasal Spray Placebo Nasal Spray Total
    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 Participants 104 104 103 311
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    31.72
    (10.61)
    30.88
    (10.71)
    31.14
    (11.62)
    31.25
    (10.54)
    Sex: Female, Male (Count of Participants)
    Female
    49
    47.1%
    53
    51%
    39
    37.9%
    141
    45.3%
    Male
    55
    52.9%
    51
    49%
    64
    62.1%
    170
    54.7%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 104 104 103
    Mean (Standard Deviation) [Score on a scale]
    -2.8
    (2.2)
    -3.4
    (2.3)
    -0.9
    (2.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Fluticasone Propionate Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.03
    Comments
    Method ANOVA
    Comments
    2. Secondary Outcome
    Title Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 103 104 103
    Mean (Standard Deviation) [Score on a scale]
    -3.2
    (2.8)
    -3.5
    (3.0)
    -1.8
    (2.9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Fluticasone Propionate Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.31
    Comments
    Method ANOVA
    Comments
    3. Secondary Outcome
    Title Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 95 95 88
    Mean (Standard Deviation) [Score on a scale]
    -4.4
    (2.9)
    -5.5
    (2.7)
    -2.7
    (3.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Fluticasone Propionate Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method ANOVA
    Comments
    4. Secondary Outcome
    Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 103 104 103
    Mean (Standard Deviation) [Score on a scale]
    -0.5
    (0.7)
    -0.7
    (0.8)
    -0.3
    (0.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.08
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Fluticasone Propionate Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.10
    Comments
    Method ANOVA
    Comments
    5. Secondary Outcome
    Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 95 95 88
    Mean (Standard Deviation) [Score on a scale]
    -0.9
    (0.8)
    -1.2
    (0.8)
    -0.5
    (0.9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Fluticasone Propionate Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method ANOVA
    Comments
    6. Secondary Outcome
    Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 103 104 103
    Mean (Standard Deviation) [Score on a scale]
    -0.6
    (0.8)
    -0.8
    (0.7)
    -0.3
    (0.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Fluticasone Propionate Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.05
    Comments
    Method ANOVA
    Comments
    7. Secondary Outcome
    Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 95 95 88
    Mean (Standard Deviation) [Score on a scale]
    -1.1
    (0.8)
    -1.3
    (0.8)
    -0.5
    (0.9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Fluticasone Propionate Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.06
    Comments
    Method ANOVA
    Comments
    8. Secondary Outcome
    Title Response to Therapy at Day 4 (Physician Evaluation)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 103 104 103
    Mean (Standard Deviation) [Score on a scale]
    3.2
    (0.9)
    3.1
    (1.1)
    3.8
    (1.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Fluticasone Propionate Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.46
    Comments
    Method ANOVA
    Comments
    9. Secondary Outcome
    Title Response to Therapy at Day 15 (Physician Evaluation)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 95 95 88
    Mean (Standard Deviation) [Score on a scale]
    2.7
    (1.1)
    2.4
    (1.1)
    3.2
    (1.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Fluticasone Propionate Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.07
    Comments
    Method ANOVA
    Comments
    10. Secondary Outcome
    Title Response to Therapy at Day 4 (Participant Evaluation)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 103 104 103
    Mean (Standard Deviation) [Score on a scale]
    3.2
    (0.9)
    3.1
    (1.1)
    3.7
    (1.1)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Fluticasone Propionate Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.53
    Comments
    Method ANOVA
    Comments
    11. Secondary Outcome
    Title Response to Therapy at Day 15 (Participant Evaluation)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 95 95 88
    Mean (Standard Deviation) [Score on a scale]
    2.6
    (1.1)
    2.4
    (1.1)
    3.4
    (1.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate Nasal Spray, Placebo Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Fluticasone Propionate Nasal Spray
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.12
    Comments
    Method ANOVA
    Comments

    Adverse Events

    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
    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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/104 (0%) 0/104 (0%) 0/103 (0%)
    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%) 0/104 (0%) 0/103 (0%)
    Other (Not Including 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 30/104 (28.8%) 24/104 (23.1%) 28/103 (27.2%)
    General disorders
    FATIGUE 1/104 (1%) 1 4/104 (3.8%) 5 6/103 (5.8%) 13
    Nervous system disorders
    HEADACHE 14/104 (13.5%) 19 13/104 (12.5%) 23 18/103 (17.5%) 28
    Respiratory, thoracic and mediastinal disorders
    COUGH 7/104 (6.7%) 12 7/104 (6.7%) 9 4/103 (3.9%) 6
    NASAL DISCOMFORT 7/104 (6.7%) 14 6/104 (5.8%) 16 4/103 (3.9%) 8
    OROPHARYNGEAL PAIN 6/104 (5.8%) 9 2/104 (1.9%) 3 4/103 (3.9%) 7

    Limitations/Caveats

    AE Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 12.0.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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

    Name/Title Senior Vice President, Global Clinical Development
    Organization Merck Sharp & Dohme Corp.
    Phone 1-800-672-6372
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT03882047
    Other Study ID Numbers:
    • I94-001
    • I94-001
    First Posted:
    Mar 20, 2019
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022