Official Title: “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 Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacodynamics Study

Study Primary Completion Date: July 2010

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.

Intervention(s) in this Clinical Trial

• Drug: salmeterol
  • Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief

Primary Measures

• PC20 to methacholine
  • Time Frame: Baseline, post 2-weeks of Advair, 36 hours after last dose of Advair
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No

Inclusion Criteria:

• Diplotype: Whites with diplotype AA or BB and African Americans with diplotype BB or CC.
• 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 MCT.
• Age: 12 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: FEV1 must be >= 60% of predicted normal values for age, height, and gender.
• MCT PC20 of [<=12]mg/ml.

Exclusion Criteria:

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Nemours Children's Clinic

Overall Clinical Trial Officials and Contacts

Kathryn Blake, Pharm.D. Principal Investigator Nemours Children's Clinic  

Overall Contact: Rena A Sprinkle, BS (904) 390-3529 rsprinkl@nemours.org

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00708227

Study ID Number: K23 HL081245-01A1

ClinicalTrials.gov Identifier: NCT00708227

Health Authority: United States: Institutional Review Board