NCT01307319

Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies

Study of Two Doses of an Investigational Nasal Aerosol Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 715 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).

Conditions

• Seasonal Allergic Rhinitis
• SAR

Interventions

Type	Name	Description
DRUG	BDP HFA	BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm.
DRUG	Placebo nasal aerosol	Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-07-01
• Completion: 2011-08-01
• First posted: 2011-03-02
• Last updated: 2015-02-20
• Results posted: 2015-02-20

Locations

45 sites across 1 country: United States