Offered by: Nemours
Location: Orlando, FL; Jacksonville, FL
What is the trial about?
This study is to find the best asthma treatment to add for African American people who have asthma that is not well controlled on a low dose of inhaled steroid. This study will also try to find out if African American children differ in how they respond to the medications used in this study.
View on clinicaltrials.gov »
Who can participate?
Children who are between the ages of 6 to 17 years old who have asthma and have not been sick with a cold over the past few weeks and can reliably perform a pulmonary function test (breathing test) can participate in the study.
What is involved?
This study has two main parts:
- run-in (2-12 weeks)
- treatment (56 weeks)
The whole study lasts up to 66-68 weeks (about 1 year and 4 months) with 15-18 study visits and 10 scheduled telephone calls. Study visits are from 15 minutes to 2.5 hours long, with most visits taking about an hour. Eight telephone calls will be scheduled during this time to check your child’s asthma. Phone calls usually take less than 10 minutes to complete. If your child’s asthma worsens during the study, you may be asked to bring them in for extra safety visits.
Study medications include fluticasone and salmeterol. Methacholine challenge will be completed once during the study, as well as sputum induction for participants =/> 12 years old. Questionnaires, breathing tests and height will be measured at all visits. Urine and blood test will be performed.
Contact Nemours Clinical Trials
Trial Name: Best African American Response to Asthma Drugs (BARD)