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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: Placebo Prednisone Capsules; Drug: Prednisone capsules; Drug: Beclomethasone dipropionate; Drug: Placebo Nasal Aerosol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01133626

BDP-AR-304

Details and patient eligibility

About

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

Enrollment: 107 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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107 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Prednisone Capsules

Drug: Placebo Nasal Aerosol

BDP HFA 320 µg/day

Experimental group

Description:

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.

Treatment:

Drug: Placebo Prednisone Capsules

Drug: Beclomethasone dipropionate

Prednisone

Active Comparator group

Description:

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.

Treatment:

Drug: Prednisone capsules

Drug: Placebo Nasal Aerosol