drugset / Trial / NCT00476099
Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD.
Timeline
- Start
- 2006-12
- Primary completion
- 2008-08
- Completion
- 2008-11
Publications
- Background Singh D, Corradi M, Spinola M, Petruzzelli S, Papi A. Extrafine beclometasone diproprionate/formoterol fumarate: a review of its effects in chronic obstructive pulmonary disease. NPJ Prim Care Respir Med. 2016 Jun 16;26:16030. doi: 10.1038/npjpcrm.2016.30.
- Results Calverley PM, Kuna P, Monso E, Costantini M, Petruzzelli S, Sergio F, Varoli G, Papi A, Brusasco V. Beclomethasone/formoterol in the management of COPD: a randomised controlled trial. Respir Med. 2010 Dec;104(12):1858-68. doi: 10.1016/j.rmed.2010.09.008. Epub 2010 Oct 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Beclomethasone | Small molecule | 100 ug | Inhaled |
| Subject | Budesonide | Small molecule | 200 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 6 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 12 ug | Inhaled |