Pharmacogenetics of b2-Agonists in Asthma.

Condition(s) targeted: Asthma

Intervention: salmeterol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Nemours Children's Clinic

Official(s) and/or principal investigator(s):
Kathryn Blake, Pharm.D., Principal Investigator, Affiliation: Nemours Children's Clinic

Overall contact:
Stacey Gray, Phone: (904) 390-3683, Email: sgray@nemours.org

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).

Official title: Pharmacogenetics of b2-Agonists in Asthma.

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

Primary outcome: PC20 to methacholine

Secondary outcome: Bronchodilator response to albuterol at time of maximum bronchoconstriction to methacholine (PC20)

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) 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.

Minimum age: 10 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Stacey Gray, Phone: (904) 390-3683, Email: sgray@nemours.org

Nemours Children's Clinic, Jacksonville, Florida 32207, United States; Recruiting

Starting date: September 2007
Ending date: July 2010
Last updated: September 17, 2009