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The objective of this study is to compare the relative bronchoprotection (at trough) conferred by 2-week chronic dosing with levosalbutamol and racemic salbutamol in mild to moderate asthmatics. Patients will be preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms. The investigators will evaluate if this has a differential effect on the bronchoprotection conferred by both formulations of salbutamol, as evidenced by a rebound in airway hyper-responsiveness, in order to determine whether any effect can be explained by the S enantiomer in the racemic formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levosalbutamol | Experimental | Patients will be asked to take two puffs four times a day for 2 weeks |
|
| 2: racemic salbutamol | Active Comparator | Patients will be asked to take two puffs four times a day for 2 weeks |
|
| 3: Placebo | Placebo Comparator | Patients will be asked to take two puffs four times a day for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levosalbutamol | Drug | Patients will be asked to take two puffs four times a day for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| methacholine challenge | before and after 2 week study period |
| Measure | Description | Time Frame |
|---|---|---|
| spirometry | before and after 2 week study period | |
| nitric oxide levels | before and after 2 week study period | |
| symptom scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karine L Clearie, MBBS, MRCP | Asthma and Allergy Research Group | Principal Investigator |
| Brian J Lipworth, MBchB | Asthma and Allergy Research Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asthma and Allergy Research Group | Dundee | Angus | DD1 9SY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23829494 | Result | Anderson WJ, Short PM, Williamson PA, Morrison AE, Palmer C, Tavendale R, Lipworth BJ. Proof-of-concept evaluation of trough airway hyper-responsiveness following regular racemic or levosalbutamol in genotype-stratified steroid-treated persistent asthmatic patients. Clin Sci (Lond). 2014 Jan 1;126(1):75-83. doi: 10.1042/CS20130213. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| racemic salbutamol | Drug | Patients will be asked to take two puffs four times a day for 2 weeks |
|
|
| placebo | Drug | Patients will be asked to take two puffs four times a day for 2 weeks |
|
| before and after 2 week study period |
| Bmax and Emax | before and after 2 week study period |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |