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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2013 by Marjorie Slankard, Columbia University.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

Marjorie Slankard, Columbia University

ClinicalTrials.gov Identifier:

NCT00521222

First received: August 24, 2007

Last updated: June 7, 2013

Last verified: June 2013

History of Changes

Purpose

The investigators are conducting a study of asthma patients who use fluticasone with salmeterol (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 fluticasone with salmeterol or substituting fluticasone with salmeterol 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 fluticasone (Flovent), the other to use fluticasone with salmeterol , 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.

The investigators 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 Drug: Fluticasone HFA


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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:

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Fluticasone furoate

U.S. FDA Resources

Further study details as provided by Marjorie Slankard, Columbia University:

Primary Outcome Measures:

Absolute change in morning peak flow [ Time Frame: Up to 16 weeks from baseline ]
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 Measures:

Absolute and percentage change in rescue inhaler use [ Time Frame: Up to 16 weeks from baseline ]
Outcome will be assessed at the end of the 16 week study period.


Enrollment:	89
Study Start Date:	June 2007
Estimated Study Completion Date:	November 2013
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arg/Arg genotype on Advair (Fluticasone with Salmeterol) HFA Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.	Drug: Fluticasone with salmeterol Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period. Other Name: Advair HFA
Active Comparator: Gly/Gly genotype on Advair (Fluticasone with Salmeterol) HFA Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA.	Drug: Fluticasone with salmeterol Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period. Other Name: Advair HFA
Experimental: Arg/Arg genotype on Fluticasone HFA Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.	Drug: Fluticasone HFA Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. Other Name: Flovent HFA
Experimental: Gly/Gly genotype on Fluticasone HFA Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.	Drug: Fluticasone HFA Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. Other Name: 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 albuterol (Proventil-HFA), a short acting b2 agonist, is replaced with a different class of bronchodilator. The investigators 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 ipratropium bromide (Atrovent-HFA), a bronchodilator which works through a different mechanism for rescue therapy; albuterol 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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Marjorie Slankard, Clinical Professor of Medicine, Pulmonary, Columbia University
ClinicalTrials.gov Identifier:	NCT00521222 History of Changes
Other Study ID Numbers:	AAAC1135
Study First Received:	August 24, 2007
Last Updated:	June 7, 2013

Keywords provided by Marjorie Slankard, 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 Fluticasone Fluticasone Propionate, Salmeterol Xinafoate Drug Combination Salmeterol Xinafoate Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Sympathomimetics Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents

ClinicalTrials.gov processed this record on June 23, 2017

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