Evaluating Long Acting Beta Agonists Used to Treat Asthma Among Those With Either Arg/Arg or Gly/Gly Genotypes (ARGARG)
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| ClinicalTrials.gov Identifier: NCT00521222 |
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Recruitment Status : Unknown
Verified June 2013 by Marjorie Slankard, Columbia University.
Recruitment status was: Active, not recruiting
First Posted : August 27, 2007
Last Update Posted : June 11, 2013
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma | Drug: Fluticasone with salmeterol Drug: Fluticasone HFA | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 89 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (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. |
| Study Start Date : | June 2007 |
| Actual Primary Completion Date : | November 2010 |
| Estimated Study Completion Date : | November 2013 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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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.
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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 |
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Experimental: Arg/Arg genotype on Fluticasone HFA
Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone.
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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 |
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Experimental: Gly/Gly genotype on Fluticasone HFA
Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone.
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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 |
- 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).
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521222
| 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 | |
| Principal Investigator: | Marjorie Slankard, M.D. | Columbia University |
| Responsible Party: | Marjorie Slankard, Clinical Professor of Medicine, Pulmonary, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00521222 History of Changes |
| Other Study ID Numbers: |
AAAC1135 |
| First Posted: | August 27, 2007 Key Record Dates |
| Last Update Posted: | June 11, 2013 |
| Last Verified: | June 2013 |
Keywords provided by Marjorie Slankard, Columbia University:
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asthma beta agonist bronchodilator pulmonary genotype |
pharmacogenomics corticosteroid allergy immunology |
Additional relevant MeSH terms:
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Salmeterol Xinafoate Fluticasone Propionate, Salmeterol Xinafoate Drug Combination 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 Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |