drugset / Trial / NCT00463866
Local Phase 4 Pan-European SMART Study
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period
Timeline
- Start
- 2007-03
- Primary completion
- —
- Completion
- 2008-12
Outcome
Met primary endpoint
paper In the total study population, the time to first severe asthma exacerbation was prolonged by 18% with 2 × 2 versus 1 × 2 (hazard ratio 0.82; p = 0.03). PMID 20595145 ↗
Publications
- Aubier M, Haughney J, Selroos O, van Schayck OC, Ekstrom T, Ostinelli J, Buhl R. Is the patient's baseline inhaled steroid dose a factor for choosing the budesonide/formoterol maintenance and reliever therapy regimen? Ther Adv Respir Dis. 2011 Oct;5(5):289-98. doi: 10.1177/1753465811407236. Epub 2011 May 17.
- Haughney J, Aubier M, Jorgensen L, Ostinelli J, Selroos O, van Schayck CP, Buhl R. Comparing asthma treatment in elderly versus younger patients. Respir Med. 2011 Jun;105(6):838-45. doi: 10.1016/j.rmed.2011.02.011. Epub 2011 Mar 23.
- Aubier M, Buhl R, Ekstrom T, Ostinelli J, van Schayck CP, Selroos O, Haughney J. Comparison of two twice-daily doses of budesonide/formoterol maintenance and reliever therapy. Eur Respir J. 2010 Sep;36(3):524-30. doi: 10.1183/09031936.00022010. Epub 2010 Jul 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | budesonide/formoterol | Unknown | 4.5 ug | Inhaled |
| Subject | budesonide/formoterol | Unknown | 160 ug | Inhaled |