Clinical trial NCT03861559: Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184)
Official title: Onset of Action of Mometasone Furoate (SCH 32088) Nasal Spray 50 mcg/Spray vs Placebo in Seasonal Allergic Rhinitis (Study No. C93-184).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Seasonal
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2019-03-04
Enrollment: 201
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo for 14 days.


Eligibility criteria: Inclusion Criteria:

* Has a 2-year history of seasonal allergic rhinitis
* Has a positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
* Is in 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
* Has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn, or nedocromil
* Has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study, or required treatment which might interfere with the study
* Is on immunotherapy with the exception of maintenance therapy
* Has a clinically significant upper respiratory or sinus infection
* Has used an investigational drug within the previous 30 days
* Has nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
* Has a history of multiple drug allergies or an allergy to antihistamines or corticoids
* Has dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
* Has rhinitis medicamentosa
* Is using of any chronic medication which could affect the course of seasonal allergic rhinitis

Primary outcomes:
measure: Median Time to Onset of Nasal Symptom Relief as Assessed by Participant Diary Responses
timeFrame: From the start of treatment until onset of symptom relief (up to Day 4)
Secondary outcomes:
measure: Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) Averaged Over 15 Days of Treatment, as Assessed by Participant
timeFrame: Baseline (3 days preceding treatment) through Day 15 (averaged over 15 days)
measure: Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 4 as Assessed by Investigator
timeFrame: Baseline (Day 1) and Day 4
measure: Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator
timeFrame: Baseline (Day 1) and Day 8
measure: Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 15 as Assessed by Investigator
timeFrame: Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.
measure: Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Investigator
timeFrame: Baseline (Day 1) and Day 4
measure: Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Investigator
timeFrame: Baseline (Day 1) and Day 8
measure: Change From Baseline in Overall Disease Condition Score at Day 15 as Assessed by Investigator
timeFrame: Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.
measure: Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Participant
timeFrame: Baseline (Day 1) and Day 4
measure: Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Participant
timeFrame: Baseline (Day 1) and Day 8
measure: Change From Baseline (CFB) in Overall Disease Condition Score at Day 15 as Assessed by Participant
timeFrame: Baseline (Day 1) and Day 15
measure: Therapeutic Response to Treatment at Day 4 as Assessed by Investigator
timeFrame: Day 4
measure: Therapeutic Response to Treatment at Day 8 as Assessed by Investigator
timeFrame: Day 8
measure: Therapeutic Response to Treatment at Day 15 as Assessed by Investigator
timeFrame: Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.
measure: Therapeutic Response to Treatment at Day 4 as Assessed by Participant
timeFrame: Day 4
measure: Therapeutic Response to Treatment at Day 8 as Assessed by Participant
timeFrame: Day 8
measure: Therapeutic Response to Treatment at Day 15 as Assessed by Participant
timeFrame: Day 15
Other outcomes:
measure: Baseline Total Nasal Symptom Score (TNSS) for Calculation of Change From Baseline Averaged Over 15 Days of Treatment as Assessed by Participant
timeFrame: Baseline (3 days preceding treatment)
measure: Baseline Total Nasal Symptom Score (TNSS) for Calculation of Change From Baseline at Days 4, 8, and 15 Visits as Assessed by Investigator
timeFrame: Baseline (Day 1)
measure: Baseline Overall Disease Condition Score for Calculation of Change From Baseline at Days 4, 8, and 15 Visits as Assessed by Investigator
timeFrame: Baseline (Day 1)
measure: Baseline Overall Disease Condition Score for Calculation of Change From Baseline at Days 4, 8, and 15 as Assessed by Participant
timeFrame: Baseline (Day 1)
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: