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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week, Clinical Study Designed to Assess the Efficacy and Safety of BDP Nasal Aerosol (80 mcg, Once Daily) in Pediatric Subjects (4 to 11 Years of Age) With PAR
The purpose of this study is to evaluate the efficacy and safety of Beclomethasone dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).
Details
| Lead sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 547 |
| Start date | 2013-01 |
| Completion | 2013-10 |
Conditions
- Allergic Rhinitis
Interventions
- BDP Nasal Aerosol
- Placebo
Primary outcomes
- Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age — Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6
Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale: * 0 = absent (no sign/symptom present) * 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) * 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period.
Countries
United States