Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Drug: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol
* Drug: Placebo Nasal Aerosol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BDP HFA 320 µg/day<br>During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. | Drug: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol<br>* Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol<br>* Other names: QNASL(TM);|
| Placebo Comparator: Placebo<br>During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily. | Drug: Placebo Nasal Aerosol<br>* HFA Vehicle Aerosol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-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. | Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM & PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (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. | Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period) | 
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement. | Baseline and Week 6 |