Clinical trial NCT03882047: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Seasonal
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2019-03-20
Enrollment: 313
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: 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.


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

Primary outcomes:
measure: Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)
timeFrame: Baseline and Day 1 through Day 15 (averaged over 15 days)
Secondary outcomes:
measure: Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation)
timeFrame: Baseline (Day 1) and Day 4
measure: Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation)
timeFrame: Baseline (Day 1) and Day 15
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation)
timeFrame: Baseline (Day 1) and Day 4
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation)
timeFrame: Baseline (Day 1) and Day 15
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation)
timeFrame: Baseline (Day 1) and Day 4
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation)
timeFrame: Baseline (Day 1) and Day 15
measure: Response to Therapy at Day 4 (Physician Evaluation)
timeFrame: Day 4
measure: Response to Therapy at Day 15 (Physician Evaluation)
timeFrame: Day 15
measure: Response to Therapy at Day 4 (Participant Evaluation)
timeFrame: Day 4
measure: Response to Therapy at Day 15 (Participant Evaluation)
timeFrame: Day 15
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: