- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03882047
Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001)
February 7, 2022 updated by: Organon and Co
Efficacy and Safety of Mometasone Furoate Aqueous Nasal Spray vs Placebo and Flonase® (Fluticasone Propionate) in Seasonal Allergic Rhinitis Patients (I94-001)
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
313
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
Mometasone furoate nasal spray, 200 mg once daily
Other Names:
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.
|
Fluticasone propionate nasal spray, 200 mg once daily
Other Names:
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.
|
Fluticasone propionate placebo matching nasal spray, once daily
Mometasone furoate placebo matching nasal spray, once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)
Time Frame: 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.
|
Baseline and Day 1 through Day 15 (averaged over 15 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation)
Time Frame: 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.
|
Baseline (Day 1) and Day 4
|
Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation)
Time Frame: 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.
|
Baseline (Day 1) and Day 15
|
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation)
Time Frame: 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.
|
Baseline (Day 1) and Day 4
|
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation)
Time Frame: 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.
|
Baseline (Day 1) and Day 15
|
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation)
Time Frame: 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.
|
Baseline (Day 1) and Day 4
|
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation)
Time Frame: 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.
|
Baseline (Day 1) and Day 15
|
Response to Therapy at Day 4 (Physician Evaluation)
Time Frame: 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.
|
Day 4
|
Response to Therapy at Day 15 (Physician Evaluation)
Time Frame: 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.
|
Day 15
|
Response to Therapy at Day 4 (Participant Evaluation)
Time Frame: 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.
|
Day 4
|
Response to Therapy at Day 15 (Participant Evaluation)
Time Frame: 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.
|
Day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 11, 1994
Primary Completion (Actual)
September 16, 1994
Study Completion (Actual)
September 16, 1994
Study Registration Dates
First Submitted
March 18, 2019
First Submitted That Met QC Criteria
March 18, 2019
First Posted (Actual)
March 20, 2019
Study Record Updates
Last Update Posted (Actual)
February 9, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Fluticasone
- Xhance
- Mometasone Furoate
Other Study ID Numbers
- I94-001 (Other Identifier: Schering-Plough Protocol Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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