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

April 12, 2023 updated by: Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Advair HFA
Drug: Ipratropium HFA
Primary as-needed rescue medication in all treatment groups
Other Names:
  • Atrovent
Drug: Albuterol HFA
Secondary as-needed rescue medication in all treatment groups
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 Names:
  • Advair HFA
Drug: Ipratropium HFA
Primary as-needed rescue medication in all treatment groups
Other Names:
  • Atrovent
Drug: Albuterol HFA
Secondary as-needed rescue medication in all treatment groups
Experimental: Arg/Arg genotype on Fluticasone HFA
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
Drug: Ipratropium HFA
Primary as-needed rescue medication in all treatment groups
Other Names:
  • Atrovent
Drug: Albuterol HFA
Secondary as-needed rescue medication in all treatment groups
Drug: Fluticasone HFA
Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Other Names:
  • 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: Ipratropium HFA
Primary as-needed rescue medication in all treatment groups
Other Names:
  • Atrovent
Drug: Albuterol HFA
Secondary as-needed rescue medication in all treatment groups
Drug: Fluticasone HFA
Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.
Other Names:
  • Flovent HFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 16 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 16 weeks from baseline
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
Up to 16 weeks from baseline
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
Up to 16 weeks from baseline
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.
Up to 16 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Marjorie Slankard, M.D., Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

August 24, 2007

First Submitted That Met QC Criteria

August 24, 2007

First Posted (Estimate)

August 27, 2007

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAC1135

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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