CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 715 enrolled
Drug / intervention
BDP HFA +1 moredrug
Likely dose
BDP HFA 80 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01307319
NCT01307319Phase 3Completed
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Study of Two Doses of an Investigational Nasal Aerosol Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Mar 2, 2011·Updated Feb 20, 2015

In Brief

A Phase 3 clinical trial evaluating BDP HFA and Placebo nasal aerosol for Seasonal Allergic Rhinitis and SAR. Completed, enrolled 715 participants across 45 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis, SAR
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2011
Enrollment StartMar 1, 2011
Primary CompletionJul 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.3 years ago

Interventions

BDP HFAdrug

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.

Placebo nasal aerosoldrug

Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.