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Pharmacogenetics of b2-Agonists in Asthma.

Information source: Nemours Children's Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: fluticasone (Drug); Salmeterol (Drug); Ipratropium bromide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Nemours Children's Clinic

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

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).

Clinical Details

Official title: Pharmacogenetics of b2-Agonists in Asthma.

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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. 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.

Eligibility

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

Criteria:

Inclusion Criteria:

- 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: 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: forced expiratory volume in the first sectond (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 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, FloventĀ® MDI, ipratropium bromide,

albuterol, or Advair DiskusĀ® 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.

Locations and Contacts

Nemours Children's Clinic, Jacksonville, Florida 32207, United States
Additional Information

Starting date: September 2007
Last updated: April 13, 2015

Page last updated: August 23, 2015

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