Status:
COMPLETED
Pharmacogenetics of b2-Agonists in Asthma.
Lead Sponsor:
Nemours Children's Clinic
Collaborating Sponsors:
University of Florida
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Eligibility:
All Genders
10+ years
Brief Summary
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).
Detailed Description
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) affect...
Eligibility Criteria
Inclusion
- Diplotype: Whites with specific diplotype and African Americans with specific diplotypes.
- Gender: Male or female. Women are eligible if they are not pregnant or lactating. Females subjects of childbearing potential will undergo a urine pregnancy test prior to each methacholine challenge test.
- Age: 10 years and older.
- Asthma Diagnosis: Physician diagnosed asthma according to American Thoracic Society criteria for at least 3 months.
- Asthma Therapy: There is no requirement for previous asthma therapy to be included in this study.
- Asthma Severity: forced expiratory volume in the first second (FEV1) must be \>= 60% of predicted normal values for age, height, and gender.
- methacholine challenge test provocative concentration (20% fall in FEV1) of \<=12\]mg/ml.
Exclusion
- History of life-threatening asthma: Any episode of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures.
- Asthma instability: Hospitalization for asthma within 3 months of Visit 1.
- Concurrent respiratory disease: Any respiratory disease other than asthma.
- Sensitivities: Sensitivities to methacholine, Flovent® MDI, ipratropium bromide, albuterol, or Advair Diskus® that would put the safety of the subject at risk.
- Respiratory Tract Infection: Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks immediately preceding Visit 1, or for which antibiotic therapy has not been completed at least 2 weeks prior to Visit 1.
- Expected exposure to pollen allergen to which the patient is sensitive (by medical history of symptoms) during the 29 day study period. These patients can be studied when pollen exposure to which they are sensitive will not occur.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00708227
Start Date
September 1 2007
End Date
August 1 2012
Last Update
February 22 2018
Active Locations (1)
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1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207