Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol (320 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Adult and Adolescent Subjects (12 Years of Age and Older)
Overview
- Phase
- Phase 3
- Intervention
- Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol
- Conditions
- Rhinitis, Allergic, Perennial
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Enrollment
- 474
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed Consent
- •Documented history of perennial allergic rhinitis
- •A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test.
- •Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12)
- •Other criteria apply
Exclusion Criteria
- •History of physical findings of nasal pathology (within 60 days prior to screening visit)
- •Participation in any investigational drug study 30 days preceding screening visit
- •History of respiratory infection/disorder with 14 days preceding screening visit or during the run-in period
- •Use of any prohibited concomitant medications
Arms & Interventions
BDP HFA 320 µg/day
During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
Intervention: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol
Placebo
During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
Intervention: Placebo Nasal Aerosol
Outcomes
Primary Outcomes
Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period
Time Frame: Baseline (Days -3 to 0) and Days 1-43 (6-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, awareness, 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 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Secondary Outcomes
- Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period(Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period))
- Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(Baseline and Week 6)