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

Phase 3

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: Placebo Nasal Aerosol; Drug: Placebo Prednisone Capsules; Drug: Beclomethasone dipropionate; Drug: Prednisone capsules

• Registration Number: NCT01133626
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-31
• Study Start: 2010-06
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Disposition First Submitted: 2011-08-25
• Disposition First Submitted QC: 2011-08-25
• Disposition First Posted: 2011-08-29
• Results First Submitted: 2012-04-23
• Status Verified: 2012-05
• Results First Submitted QC: 2012-05-31
• Last Update Submitted: 2012-05-31
• Results First Posted: 2012-07-04
• Last Update Posted: 2012-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Nasal Aerosol	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.
Placebo	Placebo Prednisone Capsules	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.
BDP HFA 320 µg/day	Placebo Prednisone Capsules	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.
BDP HFA 320 µg/day	Beclomethasone dipropionate	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.
Prednisone	Placebo Nasal Aerosol	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.
Prednisone	Prednisone capsules	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.

Primary Outcome Measures

Name	Time	Method
The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment	Day 0 (Baseline), Day 42	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.

Trial Locations

Locations (1)

Teva Clinical Study Site; 🇺🇸 San Antonio, Texas, United States