Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.

Official Title
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A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP HFA Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis When Administered in Adolescent and Adult Subjects (12 to 45 Years of Age) With Perennial Allergic Rhinitis (PAR)

Conditions
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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: Placebo Nasal Aerosol
* Drug: Prednisone capsules
* Drug: Placebo Prednisone Capsules
* Drug: Beclomethasone dipropionate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent Male or female subjects 12-45 years of age Documented history of perennial allergic rhinitis General good health Other criteria apply Exclusion Criteria: History of physical findings of nasal pathology (within 60 days prior to Screening Visit 1) Participation in any investigational drug study 30 days preceding Screening Visit 1 History of respiratory infection/disorder with 14 days preceding Screening Visit 1 Use of any prohibited concomitant medications

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 45 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone. | Drug: Placebo Nasal Aerosol<br>* Placebo nasal aerosol administered daily for 42 days of treatment<br>Drug: Placebo Prednisone Capsules<br>* Placebo prednisone capsule taken each day on the last 7 days of treatment<br>|
| Experimental: BDP HFA 320 µg/day<br>Participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone. | Drug: Placebo Prednisone Capsules<br>* Placebo prednisone capsule taken each day on the last 7 days of treatment<br>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 42 days.<br>* Other names: QNASL(TM);|
| Active Comparator: Prednisone<br>Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule. | Drug: Placebo Nasal Aerosol<br>* Placebo nasal aerosol administered daily for 42 days of treatment<br>Drug: Prednisone capsules<br>* Prednisone 10 mg capsule taken each day on the last 7 days of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment | Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an other pre-specified outcome. | Day 0 (Baseline), Day 42 |