Clinical trial NCT03855189: Safety and Efficacy of Mometasone Furoate (SCH 032088) vs Beclomethasone Dipropionate or Placebo in Seasonal Allergic Rhinitis (C93-013)
Official title: Safety and Efficacy of SCH 32088 vs Beclomethasone Dipropionate (Vancenase AQ) and Placebo in Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2019-02-26
Enrollment: 345
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 objectives of this study are to determine the safety and efficacy in seasonal allergic rhinitis of a four-week course of mometasone furoate compared to beclomethasone dipropionate or placebo.


Eligibility criteria: Inclusion Criteria:

* Nonpregnant women of childbearing potential must be using a medically acceptable form of birth control for at least 3 months prior to Screening, and must continue its use for the duration of the study. Women not of childbearing potential must be surgically sterilized or at least one year post menopausal, or be otherwise incapable of bearing children
* 2-year history of seasonal allergic rhinitis
* Positive skin test response to a local seasonal allergen within last 2 years
* 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
* Pre-menarchal females
* Asthma requiring therapy with inhaled or systemic corticosteroids
* Significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, may interfere with the study, or require treatment which might interfere with the study
* On immunotherapy (unless maintenance therapy)
* Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks
* Use of any investigational drug within the previous 90 days unless the investigational drug is a nasal corticosteroid or has a short (12 hours or less) duration of action, in which case the washout period will be 30 days
* Large nasal polyps, marked septal deviations or any other nasal structural abnormality that significantly interferes with nasal air flow
* Allergy to corticosteroids, or a history of multiple drug allergies
* History of posterior subcapsular cataracts
* Dependence upon nasal, oral or ocular decongestants or who are diagnosed with rhinitis medicamentosa
* Chronic use of any medication which could affect the course of seasonal allergic rhinitis
* Clinically significant abnormal electrocardiogram (ECG)

Primary outcomes:
measure: Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated)
timeFrame: Baseline, and Days 1 through 15 (average of 15 days of treatment)
measure: Number of Participants Who Experienced ≥1 Adverse Event
timeFrame: Up to 31 Days
measure: Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE)
timeFrame: Up to 31 Days
Secondary outcomes:
measure: Change From Baseline in the TNSS At Day 4 (Physician-Evaluated)
timeFrame: Baseline (Day 1), Day 4
measure: Change From Baseline in the TNSS At Day 8 (Physician-Evaluated)
timeFrame: Baseline (Day 1), Day 8
measure: Change From Baseline in the TNSS At Day 15 (Physician-Evaluated)
timeFrame: Baseline (Day 1), Day 15
measure: Change From Baseline in the TNSS At Day 22 (Physician-Evaluated)
timeFrame: Baseline (Day 1), Day 22
measure: Change From Baseline in the TNSS At Day 29 (Physician-Evaluated)
timeFrame: Baseline (Day 1), Day 29
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated)
timeFrame: Baseline (Day 1), Day 4
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated)
timeFrame: Baseline (Day 1), Day 8
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated)
timeFrame: Baseline (Day 1), Day 15
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated)
timeFrame: Baseline (Day 1), Day 22
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated)
timeFrame: Baseline (Day 1), Day 29
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated)
timeFrame: Baseline (Day 1), Day 4
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated)
timeFrame: Baseline (Day 1), Day 8
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated)
timeFrame: Baseline (Day 1), Day 15
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated)
timeFrame: Baseline (Day 1), Day 22
measure: Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated)
timeFrame: Baseline (Day 1), Day 29
measure: Response To Therapy At Day 4 (Physician-Evaluated)
timeFrame: Day 4
measure: Response To Therapy At Day 8 (Physician-Evaluated)
timeFrame: Day 8
measure: Response To Therapy At Day 15 (Physician-Evaluated)
timeFrame: Day 15
measure: Response To Therapy At Day 22 (Physician-Evaluated)
timeFrame: Day 22
measure: Response To Therapy At Day 29 (Physician-Evaluated)
timeFrame: Day 29
measure: Response To Therapy At Day 4 (Participant-Evaluated)
timeFrame: Day 4
measure: Response To Therapy At Day 8 (Participant-Evaluated)
timeFrame: Day 8
measure: Response To Therapy At Day 15 (Participant-Evaluated)
timeFrame: Day 15
measure: Response To Therapy At Day 22 (Participant-Evaluated)
timeFrame: Day 22
measure: Response To Therapy At Day 29 (Participant-Evaluated)
timeFrame: Day 29
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: