Evaluation of the Effect of Levalbuterol on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma
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Purpose
The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer, albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol which are mirror images of each other i.e. R-and S- isomers. The investigational treatments are R-albuterol and S-albuterol.
R-albuterol ( levalbuterol) has been shown to have a slightly better bronchodilator effect as compared to the racemic albuterol and is well- tolerated in patients. However it is still not clear whether the S-isomer has no effect or has a harmful effect on the airways.
The purpose of this study is to compare the effects of the R- and S- isomers on allergen induced airway inflammation in subjects with mild atopic asthma. This will give us a better idea as to whether the routine use of levalbuterol is superior to racemic albuterol.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: R-albuterol, S-albuterol |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Double-blind, Crossover, Placebo-controlled Evaluation of the Effect of Levalbuterol (R-albuterol) on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma |
- The change in airway eosinophil number (% and absolute numbers) following an allergen inhalation.
- Changes in:
- PC20 methacholine
- Allergen-induced early and late asthma responses
- Airway eosinophil activation (EG-2+ eosinophils)
- Levels of IL-5, RANTES, and eotaxin in sputum
- Expression of PLCß1 on airway eosinophils
| Estimated Enrollment: | 15 |
| Study Start Date: | April 2006 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer, albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol which are mirror images of each other i.e. R-and S- isomers. The investigational treatments are R-albuterol and S-albuterol .
R-albuterol ( levalbuterol) relieves the narrowing of the bronchial air passages in the lungs and has been approved by the U.S. FDA, but is not currently licensed for use in Canada. We have obtained approval from Health Canada to use these isomers for the purpose of this study. R-albuterol has been shown to have a slightly better bronchodilator effect as compared to the racemic albuterol and is well- tolerated in patients, with only a few mild to moderate side effects (such as palpitations, diarrhoea, abdominal pain, bodyache, leg cramps and headache). However it is still not clear whether the S-isomer has no effect or has a harmful effect on the airways.
The purpose of this study is to determine the effect of this drug, levalbuterol, on the allergen-induced inflammatory response in adult subjects with asthma. Specifically, we want to look for changes in airway eosinophils by examining sputum samples and to compare the effects of the R- and S- isomers on airway inflammation. This will help us to understand whether the racemic albuterol could worsen inflammation because of the presence of the S-isomer, and this will give us a better idea as to whether the routine use of levalbuterol is superior to racemic albuterol.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects age 18-55.
- Stable, mild atopic asthma with forced expiratory volume in one second (FEV1.0) greater than 70% of predicted for age and height, and not requiring any medical treatment other than short acting inhaled beta-agonists as needed.
- No recent or significant history of cigarette smoking (no cigarettes within six months prior to entry into the study; less than 10 pack-years cumulative history of cigarette smoking).
- Peak decrease in FEV1 in both early (0-2 hour) and late (3-7 hour) allergen-provoked response of > 15% compared with the baseline (pre-allergen challenge) spirometric determination.
- Signed written informed consent to participate in the protocol; ability to return to the outpatient clinic for repeated clinic visits.
- No history of asthma exacerbations or acute intercurrent respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) for a six week period preceding entry into the screening phase of the study.
Exclusion Criteria:
- Significant gastrointestinal (including hepatic), hematological, cardiovascular, cerebrovascular or other body system disorder.
- History of an acute exacerbation, or of a respiratory tract infection at any time during the past 6 weeks.
- Baseline AST or ALT (indicators of liver damage) greater than twice the upper limit of the normal range for the local laboratory.
- History of allergy or hypersensitivity to short-acting beta-agonists.
- Inability to discontinue asthma medications for the duration of the study or receipt of oral or inhaled corticosteroids or leukotriene receptor antagonist in the three weeks prior to entry into the screening phase of the study.
- Recent (within the past 2 months) or planned (within the study period) lung volume reduction surgery.
- Psychosis, alcoholism, active substance abuse, or any personality disorder which would make compliance with this protocol problematic.
- Pregnant or nursing females.
- Any other medical or social condition which, in the opinion of the investigator, could confound the interpretation of the data derived from this study.
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00320034 History of Changes |
| Other Study ID Numbers: | SRC 192 |
| Study First Received: | April 27, 2006 |
| Last Updated: | February 28, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by McMaster University:
|
levalbuterol asthma allergen provocation airway inflammation clinical trial |
Additional relevant MeSH terms:
|
Asthma Inflammation Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pathologic Processes Albuterol Tocolytic Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 16, 2013