Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Hay Fever; Seasonal Allergic Rhinitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01024608

BDP-AR-301

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 seasonal allergic rhinitis.

Enrollment: 340 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed Consent
• Male or female subjects 12 years of age or older
• Documented history of season allergic rhinitis to mountain cedar pollen
• General good health
• 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
• Use of any prohibited concomitant medications
• Other criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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340 participants in 2 patient groups, including a placebo group

BDP HFA 320 µg/day

Experimental group

Description:

During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning.

Treatment:

Drug: Beclomethasone dipropionate

Placebo

Placebo Comparator group

Description:

During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.

Treatment:

Drug: Placebo Nasal Aerosol