Back to resultsMometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001)
Primary Purpose
Rhinitis, Allergic, Seasonal
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mometasone furoate
Fluticasone propionate
Mometasone furoate placebo
Fluticasone propionate placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Seasonal
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Mometasone furoate nasal spray
Fluticasone propionate nasal spray
Placebo nasal spray
Arm Description
Participants receive 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily.
Participants receive 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily.
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily.
Outcomes
Primary Outcome Measures
Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)
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
Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation)
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.
Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation)
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.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation)
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.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation)
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.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation)
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.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation)
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.
Response to Therapy at Day 4 (Physician Evaluation)
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.
Response to Therapy at Day 15 (Physician Evaluation)
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.
Response to Therapy at Day 4 (Participant Evaluation)
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.
Response to Therapy at Day 15 (Participant Evaluation)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03882047
Brief Title
Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001)
Official Title
Efficacy and Safety of Mometasone Furoate Aqueous Nasal Spray vs Placebo and Flonase® (Fluticasone Propionate) in Seasonal Allergic Rhinitis Patients (I94-001)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 11, 1994 (Actual)
Primary Completion Date
September 16, 1994 (Actual)
Study Completion Date
September 16, 1994 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
313 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mometasone furoate nasal spray
Arm Type
Experimental
Arm Description
Participants receive 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily.
Arm Title
Fluticasone propionate nasal spray
Arm Type
Active Comparator
Arm Description
Participants receive 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily.
Arm Title
Placebo nasal spray
Arm Type
Placebo Comparator
Arm Description
Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily.
Intervention Type
Drug
Intervention Name(s)
Mometasone furoate
Other Intervention Name(s)
NASONEX®, MK-0887, SCH 032088
Intervention Description
Mometasone furoate nasal spray, 200 mg once daily
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate
Other Intervention Name(s)
FLONASE®
Intervention Description
Fluticasone propionate nasal spray, 200 mg once daily
Intervention Type
Drug
Intervention Name(s)
Mometasone furoate placebo
Intervention Description
Mometasone furoate placebo matching nasal spray, once daily
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate placebo
Intervention Description
Fluticasone propionate placebo matching nasal spray, once daily
Primary Outcome Measure Information:
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)
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001)
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