Study of the Effects of Different Long-acting Bronchodilator Medications on Asthma Patients With Different Genetic Variations (GABLE)
This study has been terminated.
Sponsor:
Brigham and Women's Hospital
Collaborators:
Harvard Clinical Research Institute
Massachusetts General Hospital
Information provided by (Responsible Party):
Elliot Israel, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00706446
First received: June 25, 2008
Last updated: March 4, 2013
Last verified: March 2013
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Purpose
This study is looking at the effects of certain long-acting bronchodilators on patients with asthma who have specific genetic variations. The investigators 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. The investigators 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 |
|---|---|
|
Asthma |
Drug: tiotropium bromide Drug: salmeterol or formoterol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Genotype Stratified Treatment With Anticholinergic vs. Beta-agonist (Long Acting) and Exacerbations (GABLE) |
Resource links provided by NLM:
MedlinePlus related topics:
Asthma
Drug Information available for:
Formoterol fumarate
Formoterol
Salmeterol
Salmeterol xinafoate
Tiotropium bromide
Arformoterol Tartrate
U.S. FDA Resources
Further study details as provided by Brigham and Women's Hospital:
Primary Outcome Measures:
- Asthma exacerbations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- FEV1 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Exhaled NO [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Symptom-free days [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Asthma-related Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 355 |
| Study Start Date: | June 2008 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Tiotropium plus inhaled steroids in the Arg/Arg genotype
|
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.
Other Name: Spiriva
|
|
Experimental: 2
Tiotropium plus inhaled steroids in the Arg/Gly genotype
|
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.
Other Name: Spiriva
|
|
Experimental: 3
Tiotropium plus inhaled steroid in the Gly/Gly genotype
|
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.
Other Name: Spiriva
|
|
Active Comparator: 4
Long-acting beta agonist plus inhaled steroid in the Arg/Arg 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.
Other Names:
|
|
Active Comparator: 5
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.
Other Names:
|
|
Active Comparator: 6
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.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical history consistent with asthma
- Has a current prescription for a long-acting beta agonist, either along or in combination with an inhaled corticosteroid (salmeterol, formoterol, fluticasone/salmeterol, or budesonide/formoterol)
- Ability to provide informed consent
- Non-smoker (total lifetime smoking history < 10 pack-years; no more than five occasions of smoking any substance or using smokeless tobacco products in the past year)
- No smoking or use of smokeless tobacco in the past 30 days
- No known contraindication to inhaled tiotropium e.g. narrow angle glaucoma, history of bladder neck obstruction or significant symptoms related to prostatic hypertrophy
Exclusion Criteria:
- Lung disease other than asthma
- Established or suspected diagnosis of vocal cord dysfunction
- Significant medical illness (other than asthma) that is not stable
- History of life-threatening asthma requiring treatment with intubation and mechanical ventilation within the past 5 years
- History of respiratory tract infection within the previous 4 weeks (only applies at screening visits)
- Hyposensitization therapy other than an established maintenance regimen
- Allergy to tiotropium
- Pregnancy or lactation. If potentially able to bear children, not using an acceptable form of birth control
- Inability to use inhaler devices
- Inability to participate over the one year period
- Current use of tiotropium
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706446
Locations
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard Clinical Research Institute
Massachusetts General Hospital
Investigators
| Principal Investigator: | Elliot Israel, MD | Brigham and Women's Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Elliot Israel, MD, Director of the Asthma Research Center, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00706446 History of Changes |
| Other Study ID Numbers: | 2008-P-000285 |
| Study First Received: | June 25, 2008 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Brigham and Women's Hospital:
|
Asthma Pharmacogenetics Beta agonists salmeterol |
formoterol tiotropium beta adrenergic receptor single nucleotide polymorphism |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Bromides Formoterol Salmeterol Tiotropium Anticonvulsants Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Parasympatholytics |
ClinicalTrials.gov processed this record on May 16, 2013