drugset / Trial / NCT00119496
Rosiglitazone Versus Theophylline in Asthmatic Smokers
Phase 2/3
Completed
79 enrolled
University of Glasgow
Chest, Heart and Stroke Association Scotland · collabChief Scientist Office of the Scottish Government · collabGlaxoSmithKline · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Asthmatic smokers display a blunted response to both inhaled and oral corticosteroid treatments and are at increased risk for exacerbations and near fatal asthma. The prevalence of smoking in asthmatics runs between 20-30%. Therefore, new, more efficacious treatments are required. Recent work has demonstrated a mechanism which may explain steroid resistance. A commonly used drug called theophylline can reverse this steroid resistance in laboratory studies. Another commonly used drug, rosiglitazone can reverse smoking induced lung inflammation in laboratory studies. The investigators aim to study the effects of these drugs on smoking asthmatics' lung function and other parameters including quality of life and asthma control.
Timeline
- Start
- 2005-07
- Primary completion
- —
- Completion
- 2007-06
Publications
- Background Spears M, McSharry C, Thomson NC. Peroxisome proliferator-activated receptor-gamma agonists as potential anti-inflammatory agents in asthma and chronic obstructive pulmonary disease. Clin Exp Allergy. 2006 Dec;36(12):1494-504. doi: 10.1111/j.1365-2222.2006.02604.x.
- Spears M, Donnelly I, Jolly L, Brannigan M, Ito K, McSharry C, Lafferty J, Chaudhuri R, Braganza G, Adcock IM, Barnes PJ, Wood S, Thomson NC. Effect of low-dose theophylline plus beclometasone on lung function in smokers with asthma: a pilot study. Eur Respir J. 2009 May;33(5):1010-7. doi: 10.1183/09031936.00158208. Epub 2009 Feb 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Beclomethasone | Small molecule | 200 ug | Inhaled |
| Comparator | Beclomethasone | Small molecule | 400 ug | Inhaled |
| Comparator | Rosiglitazone | Small molecule | 4 mg | Oral |
| Comparator | Theophylline | Small molecule | 200 mg | Oral |
| Comparator | Theophylline | Small molecule | 400 mg | Oral |