NCT01967173

Best African American Response to Asthma Drugs

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 574 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find the best asthma treatment to add for Blacks who have asthma that is not well controlled on a low dose of inhaled steroid. This study will also try to find out if Black adults and children differ in how they respond to the medications used in this study.

Detailed description

BARD is a 66 week prospective, randomized, double-blind, crossover trial in Blacks (individuals who self-report Black ancestry) who have inadequately controlled asthma while taking low-dose inhaled corticosteroids (ICS). BARD will examine the efficacy of increasing the dose of ICS with or without the addition of a long-acting beta agonist (LABA) to determine whether individual patients respond better to one treatment than another and, if so, whether the responses are different for children and adults or if they are related to genetic ancestry.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Flovent Diskus® 100 mcg	Flovent is an ICS
DRUG	Flovent Diskus® 250 mcg	Flovent is an ICS
DRUG	Flovent Diskus® 500 mcg	Flovent is an ICS
DRUG	Advair Diskus® 100/50 mcg	Advair is an ICS/LABA combination
DRUG	Advair Diskus® 250/50 mcg	Advair is an ICS/LABA combination

Timeline

• Start date: 2014-02-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2013-10-22
• Last updated: 2018-11-15
• Results posted: 2018-11-15

Locations

28 sites across 1 country: United States