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Sponsors and Collaborators: |
Nemours Children's Clinic University of Florida |
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Information provided by: | Nemours Children's Clinic |
ClinicalTrials.gov Identifier: | NCT00708227 |
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).
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: salmeterol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacodynamics Study |
Official Title: | Pharmacogenetics of b2-Agonists in Asthma. |
Estimated Enrollment: | 80 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
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. We want to find out if patients with asthma with certain genes respond in different ways to the salmeterol in Advair Diskus. We 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.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rena A Sprinkle, BS | (904) 390-3529 | rsprinkl@nemours.org |
United States, Florida | |
Nemours Children's Clinic | Recruiting |
Jacksonville, Florida, United States, 32207 |
Principal Investigator: | Kathryn Blake, Pharm.D. | Nemours Children's Clinic |
Responsible Party: | Nemours Children's Clinic ( Kathryn Blake, Principal Investigator ) |
Study ID Numbers: | K23 HL081245-01A1, K23 HL081245-01A1 |
Study First Received: | June 27, 2008 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00708227 |
Health Authority: | United States: Institutional Review Board |
Asthma Pharmacogenetics Salmeterol African American White |
Hypersensitivity Lung Diseases, Obstructive Salmeterol Ipratropium Respiratory Tract Diseases Bromides |
Lung Diseases Hypersensitivity, Immediate Fluticasone Asthma Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Adrenergic Agents Adrenergic beta-Agonists Molecular Mechanisms of Pharmacological Action Bronchial Diseases Immune System Diseases Cholinergic Antagonists Physiological Effects of Drugs |
Anti-Asthmatic Agents Anti-Allergic Agents Cholinergic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |