Clinical trial NCT03879772: Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)
Official title: Dose-Ranging Study of Mometasone Furoate Nasal Spray (SCH 32088) in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (Protocol C95-161)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Seasonal
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2019-03-19
Enrollment: 679
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages 6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.


Eligibility criteria: Inclusion Criteria:

* Have at least a one-year history of seasonal allergic rhinitis which previously required treatment for tree and/or grass pollen
* Have a positive skin test response to an appropriate tree and/or grass seasonal allergen within the last year.
* Must be free of any clinically significant disease other than seasonal allergic rhinitis.
* Must be pre-menarcheal.

Exclusion Criteria:

* History of asthma which requires chronic use of inhaled or systemic corticosteroids.
* Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
* History of rhinitis medicamentosa.
* History of clinically significant nasal candidiasis.
* History of multiple drug allergies or allergy/intolerance to corticosteroids or antihistamines.
* History of upper respiratory tract or sinus infection that required antibiotic therapy within the previous 2 weeks, or viral upper respiratory infection within 7 days prior to Screening.
* History of nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow.
* History of dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines.
* History of investigational drug use in the last 30 days.
* History of immunotherapy (desensitizing therapy), unless on a stable maintenance schedule for at least one month prior to Screening.

Primary outcomes:
measure: Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator
timeFrame: Baseline (Day 1) and Day 8
Secondary outcomes:
measure: Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator
timeFrame: Baseline (Day 1) and Day 4
measure: Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator
timeFrame: Baseline (Day 1) and Day 15
measure: Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator
timeFrame: Baseline (Day 1) and Day 29
measure: Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant
timeFrame: Baseline and Days 1 through 15 (average over 15 days)
measure: Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant
timeFrame: Baseline and Days 16 through 29 (average over 15 days)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: