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Completed

NCT Number: NCT00521222

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack University Medical Center, Hackensack, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Forced expiratory volume at one second (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

Treatment and study plan

Fluticasone with salmeterol

Drug

Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period.

Other names: Advair HFA

Fluticasone HFA

Drug

Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.

Other names: Flovent HFA

Ipratropium HFA

Drug

Primary as-needed rescue medication in all treatment groups

Other names: Atrovent

Albuterol HFA

Drug

Secondary as-needed rescue medication in all treatment groups

Primary outcomes

  1. 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). Peak flow measurement is a test to measure air flowing out of the lung.

Secondary outcomes

  1. Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-Bronchodilator

    Time frame: Up to 16 weeks from baseline

    Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-Bronchodilator as measured by spirometry

  2. Change in Forced Expiratory Volume in 1 Second (FEV1) Post-Bronchodilator

    Time frame: Up to 16 weeks from baseline

    Change in Forced Expiratory Volume in 1 Second (FEV1) Post-Bronchodilator as measured by spirometry

  3. Change in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted Pre-Bronchodilator

    Time frame: Up to 16 weeks from baseline

    Change in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted Pre-Bronchodilator as measured by spirometry

  4. Change in Asthma Symptom Score

    Time frame: Up to 16 weeks from baseline

    Asthma symptom score measures asthma symptoms on a scale from 0 to 3. 0 = No asthma symptoms; 1 = 1-3 asthma episodes each lasting 2 hours or less, all mild; 2= 4 or more asthma episodes that interfered with activity, play, school, or sleep for less than 2 hours; 3= 1 or more asthma episodes lasting longer than 2 hours, or resulting in shortening normal activity, or seeing a doctor, or going to a hospital. A higher score indicates a worse outcome.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Acronym: ARGARG

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 27, 2007
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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