NCT00109668

Evaluation of Two Doses of QVAR Versus Placebo by Breath Operated and Metered Dose Inhalers in Moderate Asthmatic Adolescents and Adults on a Stable Regimen of Inhaled Corticosteroids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 415 (planned)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

QVAR in a standard press and breath inhaler (QVAR-MDI) has been approved by the Food and Drug Administration (FDA) for use in the United States. The purpose of this study is to determine the level of asthma control when comparing the safety and effectiveness of QVAR in two different devices, a metered dose inhaler (MDI) and a breath operated inhaler (BOI).

Detailed description

This investigation is a multicenter, randomized, placebo and active controlled, double-blind, double-dummy, parallel-group study to evaluate the safety and efficacy of two doses of QVAR-BOI in adolescents and adults.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	beclomethasone dipropionate (QVAR)

Timeline

• Start date: 2004-07-31
• Primary completion: 2006-09-30
• Completion: 2006-09-30
• First posted: 2005-05-03
• Last updated: 2021-12-08

Locations

32 sites across 2 countries: United States, Puerto Rico