Pharmacogenetics of b2-Agonists in Asthma. - Full Text View

Sponsor:	Nemours Children's Clinic
Collaborator:	University of Florida
Information provided by:	Nemours Children's Clinic
ClinicalTrials.gov Identifier:	NCT00708227

Purpose

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:	Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pharmacogenetics of b2-Agonists in Asthma.

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Asthma

Drug Information available for: Ipratropium bromide Ipratropium Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Advair

U.S. FDA Resources

Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:

PC20 to methacholine [ Time Frame: Baseline, post 2-weeks of Advair, 36 hours after last dose of Advair ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	September 2007
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

Other Names:

Flovent (fluticasone propionate)
Advair (fluticasone propionate and salmeterol xinofoate)
Atrovent (ipratropium bromide)

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

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708227

Contacts

Contact: Stacey Gray

(904) 697-3683

slgray@nemours.org

Locations

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

Sponsors and Collaborators

Nemours Children's Clinic

University of Florida

Investigators

Principal Investigator:

Kathryn Blake, Pharm.D.

Nemours Children's Clinic

More Information

No publications provided

Responsible Party:	Kathryn Blake, Principal Investigator, Nemours Children's Clinic
ClinicalTrials.gov Identifier:	NCT00708227 History of Changes
Other Study ID Numbers:	K23 HL081245-01A1, K23 HL081245-01A1
Study First Received:	June 27, 2008
Last Updated:	September 8, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Nemours Children's Clinic:

Asthma
Pharmacogenetics
Salmeterol
African American
White

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ipratropium
Salmeterol
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on February 09, 2012