Evaluating Long Acting Beta Agonists Used to Treat Asthma Among Those With Either Arg/Arg or Gly/Gly Genotypes

Condition(s) targeted: Asthma

Intervention: fluticasone with salmeterol or fluticasone alone (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Columbia University

Official(s) and/or principal investigator(s):
Marjorie Slankard, M.D., Principal Investigator, Affiliation: Columbia University Medical Center

Overall contact:
Marjorie L Slankard, M.D., Phone: 212-326-8410, Email: ms53@columbia.edu

We are conducting a study of asthma patients who use Advair or any other combination of an inhaled corticosteroid (ICS) and a long acting beta agonist (LABA) to manage their asthma symptoms.

Participants begin the study by continuing to use Advair or substituting Advair for their current ICS/LABA medication at their regular dose or the comparable dose(all study medications are provided) for a six-week period. Patients are then separated into 2 groups: one group is asked to use Flovent, the other to use Advair, twice daily over a 16-week period (patients will need to be seen monthly during this time). Neither study personnel nor patients will know which drug is being used.

Patients are also asked to use a peak flow meter and record their daily results on a form, along with the number of puffs they use of their rescue inhaler each day. They also record any changes in asthma medications and information on any asthma episodes.

We hypothesize that there are certain patients with asthma who will do better when a long acting beta agonist is removed from their maintenance asthma medications.

Official title: Arg/Arg Genotype and Long Acting Beta Agonists in Asthma. Improved Quality of Care for Patients With Asthma.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Primary outcome measure will be absolute change in morning peak flow at the end of the 16-week study period compared with baseline (last two weeks of run-in).

Secondary outcome: Absolute and percentage change in rescue inhaler use.

Detailed description: Beta 2 (b2) agonists are the most common type of bronchodilator used to treat asthma. Beta 2 (b2) agonists are agents that bind to b2 receptors and cause muscle relaxation of the airways. There are different variants of the gene (genotypes) that influence how b2 agonists perform among the population.

A recent study demonstrated that patients with mild asthma and the Arg/Arg variant at the 16th amino acid position have improved lung function and asthma control when Proventil, a short acting b2 agonist, is replaced with a different class of bronchodilator. We plan to study asthma patients with distinct genetic makeups of the b2 receptor; specifically Arg/Arg and Gly/Gly.

Throughout the treatment period, patients will be instructed to use Atrovent-HFA (a bronchodilator which works through a different mechanism) for rescue therapy; Proventil-HFA will be available for use if necessary.

The goal of this study is to determine if the withdrawal of a beta 2 agonist leads to improved asthma control in those asthmatic patients with the Arg/Arg genotype compared with those with the Gly/Gly genotype.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 18 years or older

- History of moderate or severe and persistent asthma

- Currently being treated with a long acting beta agonist and inhaled corticosteroid

- FEV1 > or = 70% at randomization visit (pulmonary function test result)

- Women of childbearing potential must be on an effective form of

contraception

- Ability to read and understand English

Exclusion Criteria:

- Active smoking or greater than 10-pack-year history of smoking

- History of intubation for asthma within the past 10 years

- Patients who are pregnant, become pregnant during the study or are breast feeding

- Major comorbidity including: severe cardiac disease, uncontrolled hypertension, poorly

controlled diabetes, malignancy within the past 5 years (except non-melanoma skin lesions), and pulmonary disease other than asthma

Marjorie L Slankard, M.D., Phone: 212-326-8410, Email: ms53@columbia.edu

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States; Recruiting
Barbara McGoey, R.N., Phone: 201-996-5458, Email: bmcgoey@humed.com
Mary Ann Michelis, M.D., Phone: 201-996-2065, Email: mmichelis@humed.com
Mary Ann Michelis, M.D., Principal Investigator
Jin P. Guo, M.D., Sub-Investigator

Columbia University Medical Center Eastside, New York, New York 10022, United States; Recruiting
Marjorie L. Slankard, M.D., Phone: 212-326-8410, Email: ms53@columbia.edu
Kristine Ferree, R.N., Phone: 212-326-8410, Email: kferree@gmail.com
Marjorie Slankard, M.D., Principal Investigator
Emily DiMango, M.D., Sub-Investigator

Columbia Presbyterian Medical Center, New York, New York 10032, United States; Recruiting
Stephen Canfield, M.D., Phone: 212-305-6086, Email: smc12@columbia.edu
Emily DiMango, M.D., Phone: 212-305-0631, Email: ead3@columbia.edu
Stephen Canfield, M.D., Sub-Investigator
Emily DiMango, M.D., Sub-Investigator

Starting date: June 2007
Ending date: December 2009
Last updated: August 14, 2008