A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate Hydrofluoroalkane (BDP HFA) Nasal Aerosol in Subjects 12 Years of Age and Older With SAR
Overview
- Phase
- Phase 3
- Intervention
- Beclomethasone dipropionate
- Conditions
- Seasonal Allergic Rhinitis
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Enrollment
- 340
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period
- Status
- Completed
- Last Updated
- 4 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 seasonal allergic rhinitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed Consent
- •Male or female subjects 12 years of age or older
- •Documented history of season allergic rhinitis to mountain cedar pollen
- •General good health
- •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
- •Use of any prohibited concomitant medications
- •Other criteria apply
Arms & Interventions
BDP HFA 320 µg/day
During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning.
Intervention: Beclomethasone dipropionate
Placebo
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Intervention: Placebo Nasal Aerosol
Outcomes
Primary Outcomes
Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period
Time Frame: Baseline (Days -3 to 0), and Days 1-15
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping). The rTNSS (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 Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period(Baseline (Days -3 to 0), and Days 1-15)
- Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline(Day 0 (Baseline), Day 15)
- Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period(Baseline (Days -3 to 0), and Days 1-15)