Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol; Drug: Placebo Nasal Aerosol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01134705

BDP-AR-302

Details and patient eligibility

About

The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.

Enrollment: 474 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed Consent
• Documented history of perennial allergic rhinitis
• A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test.
• Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12)
• Other criteria apply

Exclusion criteria

• History of physical findings of nasal pathology (within 60 days prior to screening visit)
• Participation in any investigational drug study 30 days preceding screening visit
• History of respiratory infection/disorder with 14 days preceding screening visit or during the run-in period
• Use of any prohibited concomitant medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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474 participants in 2 patient groups, including a placebo group

BDP HFA 320 µg/day

Experimental group

Description:

During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.

Treatment:

Drug: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol

Placebo

Placebo Comparator group

Description:

During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.

Treatment:

Drug: Placebo Nasal Aerosol