Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Beclomethasone dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week, Clinical Study Designed to Assess the Efficacy and Safety of BDP Nasal Aerosol (80 mcg, Once Daily) in Pediatric Subjects (4 to 11 Years of Age) With PAR

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: BDP Nasal Aerosol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects 4 to 11 years of age, inclusive, as of the Screening Visit (SV). A documented history of PAR to a relevant perennial allergen for a minimum of 12 months (6 months for subjects 4 to 5 years of age) immediately preceding the study Screening Visit (SV). A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test. 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 (e.g., nasal piercing) or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit [SV]). 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 beta-agonists and any controller drug (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. Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial. Other criteria apply.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 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 Nasal Aerosol 80 mcg/day<br>BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period. | Drug: BDP Nasal Aerosol<br> <br> * Other names: QNASL®;|
| Placebo Comparator: Placebo Nasal Aerosol<br>Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age | Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale: 0 = absent (no sign/symptom present) 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period. | Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age | Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale: 0 = absent (no sign/symptom present) 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period. | Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6 | 
| Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age | Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale: 0 = absent (no sign/symptom present) 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period. | Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6 | 
| Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age | Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale: 0 = absent (no sign/symptom present) 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period. | Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allergic rhinitis, pediatric subjects, BDP nasal aerosol