NCT01024608

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate Hydrofluoroalkane (BDP HFA) Nasal Aerosol in Subjects 12 Years of Age and Older With SAR

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Seasonal Allergic Rhinitis
• Hay Fever

Interventions

Type	Name	Description
DRUG	Beclomethasone dipropionate	Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks.
DRUG	Placebo Nasal Aerosol	Placebo nasal aerosol administered each morning for two weeks.

Timeline

• Start date: 2009-12-31
• Primary completion: 2010-02-28
• Completion: 2010-02-28
• First posted: 2009-12-03
• Last updated: 2021-12-03
• Results posted: 2012-05-23

Locations

4 sites across 1 country: United States