Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

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 seasonal allergic rhinitis.

Official Title
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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

Conditions
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Seasonal Allergic Rhinitis, Hay Fever

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


Participation Criteria
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Eligibility Criteria
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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

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 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning. | Drug: Beclomethasone dipropionate<br>* Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks.<br>* Other names: QNASL(TM);|
| Placebo Comparator: Placebo<br>During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning. | Drug: Placebo Nasal Aerosol<br>* Placebo nasal aerosol administered each morning for two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period | 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. | Baseline (Days -3 to 0), and Days 1-15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 10 minutes (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). The iTNSS (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 1-15 | 
| Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of 'emotional' utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement. | Day 0 (Baseline), Day 15 | 
| Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period | Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) 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 (sign/symptoms hard to tolerate, interfere with daily activities). The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement. | Baseline (Days -3 to 0), and Days 1-15 |