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Sponsored by: |
University of Dundee |
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Information provided by: | University of Dundee |
ClinicalTrials.gov Identifier: | NCT00830882 |
The objective of this study is to compare the peak dose relative bronchoprotection offered by levosalbutamol and racemic salbutamol in mild to moderate asthmatics preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: levosalbutamol Drug: racemic salbutamol Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Proof of Concept Study to Evaluate the Peak Bronchoprotection Conferred by Single and Chronic Dosing With Levosalbutamol and Racemic Salbutamol in Persistent Asthmatics. |
Estimated Enrollment: | 30 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1:levosalbutamol: Experimental
2 puffs four times a day for 2 weeks
|
Drug: levosalbutamol
2 puffs four times a day for 2 weeks
|
2: racemic salbutamol: Active Comparator
2 puffs four times a day for 2 weeks
|
Drug: racemic salbutamol
2 puffs four times a day for 2 weeks
|
3: Placebo: Placebo Comparator
2 puffs four times a day for 2 weeks
|
Drug: placebo
2 puffs four times a day for 2 weeks
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: karine L Clearie, MBBS, MRCP | 01382 496440 ext 36440 | k.clearie@dundee.ac.uk |
Contact: Brian J Lipworth, MBchB | 01382496440 ext 36440 | brianlipworth@googlemail.com |
United Kingdom, Angus | |
Asthma and Allergy Research Group | Recruiting |
Dundee, Angus, United Kingdom, DD1 9SY | |
Contact: Karine L Clearie, MBBS 01382496440 ext 36440 k.clearie@dundee.ac.uk | |
Contact: Brian J Lipworth, MBchB 01382496440 ext 36440 brianlipworth@googlemail.com |
Principal Investigator: | Karine L Clearie, MBBS, MRCP | Asthma and Allergy Research Group |
Study Director: | Brian J Lipworth, MBchB | Asthma and Allergy Research Group |
Responsible Party: | Asthma and Allergy Research Group ( Dr Karine Clearie ) |
Study ID Numbers: | NAI007 |
Study First Received: | January 27, 2009 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00830882 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
asthma levosalbutamol genotype bronchoprotection |
Neurotransmitter Agents Adrenergic beta-Agonists Bronchial Diseases Adrenergic Agents Albuterol Asthma Anti-Asthmatic Agents Adrenergic Agonists |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Albuterol Physiological Effects of Drugs Reproductive Control Agents Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Tocolytic Agents |
Therapeutic Uses Immune System Diseases Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |