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

Sponsor:	Columbia University
Information provided by (Responsible Party):	Columbia University
ClinicalTrials.gov Identifier:	NCT00521222

Purpose

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.

Condition	Intervention
Asthma	Drug: fluticasone with salmeterol or fluticasone alone

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Arg/Arg Genotype and Long Acting Beta Agonists in Asthma. Improved Quality of Care for Patients With Asthma.

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

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). [ Time Frame: Outcome will be assessed at the end of the 16-week study period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Absolute and percentage change in rescue inhaler use. [ Time Frame: Outcome wil be assessed at the end of the 16 week study period. ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2007
Estimated Study Completion Date:	November 2012
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Arm 1 of the study consists of asthma patients who have the Arg/Arg genotype.	Drug: fluticasone with salmeterol or fluticasone alone Randomization will be to fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, or to fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. Other Name: Advair HFA and Flovent HFA
Experimental: 2 Arm 2 of the study consists of patients who have the Gly/Gly phenotype.	Drug: fluticasone with salmeterol or fluticasone alone Randomization will be to fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, or to fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. Other Name: Advair HFA and Flovent HFA

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521222

Locations

United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Columbia University Medical Center Eastside
New York, New York, United States, 10022
Columbia Presbyterian Medical Center
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator:

Marjorie Slankard, M.D.

Columbia University

More Information

No publications provided

Responsible Party:	Columbia University
ClinicalTrials.gov Identifier:	NCT00521222 History of Changes
Other Study ID Numbers:	AAAC1135
Study First Received:	August 24, 2007
Last Updated:	February 8, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

asthma
beta agonist
bronchodilator
pulmonary
genotype

pharmacogenomics
corticosteroid
allergy
immunology

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 12, 2012