Pharmacogenetics of b2-Agonists in Asthma.
This study will help to find out if having a certain genetic makeup influences how a person with asthma responds to salmeterol, one of the two drugs in Advair(R).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacogenetics of b2-Agonists in Asthma.|
- PC20 to methacholine [ Time Frame: Baseline, post 2-weeks of Advair, 36 hours after last dose of Advair ] [ Designated as safety issue: No ]
- Bronchodilator response to albuterol at time of maximum bronchoconstriction to methacholine (PC20) [ Time Frame: Baseline, post 2-weeks of Advair, 36 hours after last dose of Advair ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
- Flovent (fluticasone propionate)
- Advair (fluticasone propionate and salmeterol xinofoate)
- Atrovent (ipratropium bromide)
Patients are being asked to take part in this research study because they have asthma. This clinical research study is being done to see if an asthmatic's gene make-up (DNA is made up of genes) affects the way they respond to a particular asthma medication called salmeterol. Certain genes make people tall or short. Certain genes give people brown or black hair. Similarly, certain genes may be associated with the way patients respond to asthma medications.
Salmeterol xinafoate (a long acting bronchodilator) and fluticasone propionate (an inhaled corticosteroid) are the medicines contained in Advair Diskus. During this study, patients with asthma will receive fluticasone inhaler (called Flovent) and Advair Diskus. The investigators want to find out if patients with asthma with certain genes respond in different ways to the salmeterol in Advair Diskus. The investigators also want to find out if patients with asthma with certain genes who are treated with salmeterol for two weeks have their airways open up less than usual when they use albuterol.
|United States, Florida|
|Nemours Children's Clinic|
|Jacksonville, Florida, United States, 32207|
|Principal Investigator:||Kathryn Blake, Pharm.D.||Nemours Children's Clinic|