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

NCT01133626 | Completed Phase 3 Results

• 1 other identifier: BDP-AR-304
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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; Drug: Placebo Prednisone Capsules

BDP HFA 320 µg/day

EXPERIMENTAL

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; Drug: Beclomethasone dipropionate

Prednisone

ACTIVE COMPARATOR

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; Drug: Prednisone capsules

Interventions

Placebo Nasal Aerosol DRUG

Placebo nasal aerosol administered daily for 42 days of treatment

Placebo; Prednisone

Prednisone capsules DRUG

Prednisone 10 mg capsule taken each day on the last 7 days of treatment

Prednisone

Placebo Prednisone Capsules DRUG

Placebo prednisone capsule taken each day on the last 7 days of treatment

BDP HFA 320 µg/day; Placebo

Beclomethasone dipropionate DRUG

Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 42 days.

Also known as: QNASL(TM)

BDP HFA 320 µg/day

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Informed Consent
• Male or female subjects 12-45 years of age
• Documented history of perennial allergic rhinitis
• General good health
• Other criteria apply

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (3)

Teva Clinical Study Site

North Dartmouth, Massachusetts, 02747, United States

Location

Teva Clinical Study Site

New Braunfels, Texas, 78130, United States

Location

Teva Clinical Study Site

San Antonio, Texas, 78229, United States

Location

Related Publications (3)

• Hampel FC, Ratner PH, Miller SD, Melchior A, Dunbar SA, Tantry SK, Dorinsky PM. Once-daily treatment with beclomethasone dipropionate hydrofluoroalkane nasal aerosol (320 mcg/d) is not associated with hypothalamic-pituitary-adrenal axis suppression in adolescent subjects with perennial allergic rhinitis. J Allergy Clin Immunol 2012; 129:AB188

  RESULT

• Ratner PH, Miller SD, Hampel FC, A, Dunbar SA, Tantry SK, Dorinsky PM (2011). BDP HFA Nasal Aerosol 320 μg Once Daily g Once Daily Is Not Associated with HPA-Axis Suppression in Subjects With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.

  RESULT

• Ratner PH, Miller SD, Hampel FC Jr, Melchior A, Dunbar SA, Tantry SK. Once-daily treatment with beclomethasone dipropionate nasal aerosol does not affect hypothalamic-pituitary-adrenal axis function. Ann Allergy Asthma Immunol. 2012 Nov;109(5):336-41. doi: 10.1016/j.anai.2012.08.005.

  PMID: 23062389 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Prednisone; Beclomethasone

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Steroids, Chlorinated

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Sudeesh K. Tantry, Ph.D.

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 31, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 4, 2012
• Results First Posted: July 4, 2012

Record last verified: 2012-05

Locations

US (3)