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| Sponsors and Collaborators: |
Brigham and Women's Hospital Harvard Clinical Research Institute Massachusetts General Hospital |
| Information provided by: | Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00706446 |
Purpose
This study is looking at the effects of certain long-acting bronchodilators on patients with asthma who have specific genetic variations. We are interested in a certain common genetic variation in the receptor for beta-agonists, which is found in as many of one-sixth of the population. There is evidence that patients with asthma who have this variation may not do as well when treated with albuterol on a regular basis. We will be looking at whether patients with this variation have more asthma exacerbations over the course of a year when treated with salmeterol or formoterol, which are long-acting forms of albuterol; and whether these patients have fewer exacerbations when treated with tiotropium, which is a different long-acting bronchodilator that does not act at this receptor. In both groups patients will also be receiving inhaled steroids.
| Condition | Intervention |
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Asthma |
Drug: tiotropium bromide Drug: salmeterol or formoterol |
| MedlinePlus related topics: | Asthma |
| Drug Information available for: | Tiotropium Tiotropium bromide Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Symbicort Salmeterol Salmeterol xinafoate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Genotype Stratified Treatment With Anticholinergic vs. Beta-Agonist (Long Acting) and Exacerbations (GABLE) |
| Estimated Enrollment: | 438 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Tiotropium plus inhaled steroids in the Arg/Arg genotype
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Drug: tiotropium bromide
tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
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2: Experimental
Tiotropium plus inhaled steroids in the Arg/Gly genotype
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Drug: tiotropium bromide
tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
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3: Experimental
Tiotropium plus inhaled steroid in the Gly/Gly genotype
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Drug: tiotropium bromide
tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.
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4: Active Comparator
Long-acting beta agonist plus inhaled steroid in the Arg/Arg genotype
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Drug: salmeterol or formoterol
salmeterol diskus 1 puff twice a day or formoterol inhaler 2 puffs twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.
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|
5: Active Comparator
Long-acting beta agonist plus inhaled steroid in the Arg-Gly genotype
|
Drug: salmeterol or formoterol
salmeterol diskus 1 puff twice a day or formoterol inhaler 2 puffs twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.
|
|
6: Active Comparator
Long-acting beta agonist plus inhaled steroid in the Gly-Gly genotype
|
Drug: salmeterol or formoterol
salmeterol diskus 1 puff twice a day or formoterol inhaler 2 puffs twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.
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Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Stefanie Dutile | 617-732-8266 |
| United States, Massachusetts | |||||
| Brigham and Women's Hospital | Recruiting | ||||
| Boston, Massachusetts, United States, 02115 | |||||
| Principal Investigator: Elliot Israel, MD | |||||
| Massachusetts General Hospital | Recruiting | ||||
| Boston, Massachusetts, United States, 02114 | |||||
| Principal Investigator: Fiona Gibbons, MD | |||||
| Brigham and Women's Hospital |
| Harvard Clinical Research Institute |
| Massachusetts General Hospital |
| Principal Investigator: | Elliot Israel, MD | Brigham and Women's Hospital |
More Information
Brigham and Women's Hospital Asthma Research Center
|
| Responsible Party: | Brigham and Women's Hospital ( Elliot Israel, MD ) |
| Study ID Numbers: | 2008-P-000285 |
| First Received: | June 25, 2008 |
| Last Updated: | June 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00706446 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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