drugset / Trial / NCT00496470
Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.
Timeline
- Start
- 2007-05
- Primary completion
- 2008-06
- Completion
- 2008-06
Publications
- Nielsen R, Kankaanranta H, Bjermer L, Lange P, Arnetorp S, Hedegaard M, Stenling A, Mittmann N. Cost effectiveness of adding budesonide/formoterol to tiotropium in COPD in four Nordic countries. Respir Med. 2013 Nov;107(11):1709-21. doi: 10.1016/j.rmed.2013.06.007. Epub 2013 Jul 13.
- Mittmann N, Hernandez P, Mellstrom C, Brannman L, Welte T. Cost effectiveness of budesonide/formoterol added to tiotropium bromide versus placebo added to tiotropium bromide in patients with chronic obstructive pulmonary disease: Australian, Canadian and Swedish healthcare perspectives. Pharmacoeconomics. 2011 May;29(5):403-14. doi: 10.2165/11590380-000000000-00000.
- Partridge MR, Miravitlles M, Stahl E, Karlsson N, Svensson K, Welte T. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD. Eur Respir J. 2010 Jul;36(1):96-104. doi: 10.1183/09031936.00123709. Epub 2009 Nov 6.
- Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, Kessler R. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Oct 15;180(8):741-50. doi: 10.1164/rccm.200904-0492OC. Epub 2009 Jul 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | budesonide/formoterol | Unknown | 9 ug | Inhaled |
| Comparator | budesonide/formoterol | Unknown | 320 ug | Inhaled |
| Comparator | Tiotropium | Other / unclassified | 18 ug | Inhaled |