Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis

Study Overview
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Brief Summary
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Subjects with perennial allergic rhinitis will be randomized to 320 mcg of beclomethasone dipropionate (BDP) using a hydrofluoroalkane (HFA) propellant or placebo as a nasal aerosol. The subjects will be followed for safety and efficacy for a period of 30 or 52 weeks. BDP HFA is a steroid which is currently FDA approved for the treatment of asthma. BDP-HFA should be safe and effective as a dry nasal aerosol which may be preferred by some patients.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Long-term Efficacy and Safety of BDP HFA Nasal Aerosol (320 mcg, Once Daily) in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)

Conditions
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Rhinitis, Allergic, Perennial

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: Male or female subjects, 12 years of age or older as of the Screening Visit (SV) General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study A history of PAR to a relevant perennial allergen for a minimum of two years immediately preceding the study Screening Visit (SV). The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past, and in the investigator's judgment is expected to require treatment throughout the entire study A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the diluent control wheal for the skin prick test. Documentation of a positive result 12 months prior to Screening Visit (SV) is acceptable Other criteria apply Exclusion Criteria: History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, including nasal piercing, or surgery and atrophic rhinitis or rhinitis medicamentosa (all within the last 60 days prior to Screening Visit [SV]) Participation in any investigational drug study within the 30 days preceding the Screening Visit (SV) or planned participation in another investigational drug study at any time during this study History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis, or influenza within the 14 days preceding the Screening Visit (SV) or development of a respiratory infection during the Run-In Period Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists and any controller drugs (e.g., theophylline, leukotriene antagonists). History of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable. Other criteria apply Randomization Criteria Subject continues to be in general good health, meeting the selection criteria Subject has a minimum subject-reported reflective TNSS of an average of 5 (out of a possible 12) on the last 7 days during the Run-In Period The subject-reported scores for rhinorrhea or nasal congestion must be an average of 2 or greater during the last 7 days of the Run-In Period Each subject must have adequately completed the electronic AR Assessment Diary (failure is defined as missing the diary entry on more than 2 calendar days during the last 7 days of the Run-In Period) 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BDP HFA 320 µg/day<br>During the 30-week (or 52-week, depending upon investigator site) 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 30-weeks (or 52-weeks, depending upon investigator site).<br>* Other names: QNASL(TM);|
| Placebo Comparator: Placebo<br>During the 30-week (or 52-week, depending upon investigator site) 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 daily for 30-weeks (or 52-weeks, depending upon investigator site).<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-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement. | Baseline (Days -6 to 0), Day 1 to Week 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement. | Baseline (Days -6 to 0), Day 1 to Week 30 | 
| Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement. | Baseline (Days -6 to 0), Day 1 to Week 52 | 
| Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement. | Baseline (Days -6 to 0), Day 1 to Week 52 | 
| Change From Baseline to Week 30 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 (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. Week 30 scores were compared to baseline scores. A negative change score indicates improvement. | Day 0 (Baseline) and Week 30 | 
| Change From Baseline to Week 52 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 (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. Week 52 scores were compared to baseline scores. A negative change score indicates improvement. | Day 0 (Baseline) and Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BDP-HFA, Rhinitis, Allergic, Perennial, Hay fever, Allergic rhinitis