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Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Range-Finding Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Adult and Adolescent Patients (12 Years and Older) With Seasonal Allergic Rhinitis (SAR)
This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.
Details
| Lead sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 487 |
| Start date | 2009-03 |
| Completion | 2009-05 |
Conditions
- Seasonal Allergic Rhinitis
- Hayfever
Interventions
- Beclomethasone dipropionate HFA Nasal Aerosol
- Placebo
Primary outcomes
- Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period — Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \& PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Countries
United States