SPIRIVA in Ususal Care

Summary

The objective of the study is to determine the effect on lung function when either SPIRIVA once daily or placebo once daily is added to the usual therapy (care) of COPD patients naïve to anticholinergic agents managed in primary care. Previous studies have been in both hospital in and outpatients, with washout of some respiratory medications, this is the first study to be conducted in General Practice, the drug's anticipated environment. Data from this study, including the adverse event monitoring, and post study findings on physical examination, will be used to extend the safety database. Health Resource Utilisation (HRU) data will be recorded to be use with data from other sources for economic analysis of COPD treatment.

Timeline

Start

2002-10

Primary completion

2003-10

Completion

2003-10

Outcome

Met primary endpoint

paper At Week 12, median improvement in trough FEV1 response with tiotropium versus placebo was 0.06 L (p = 0.0102). PMID 17605774 ↗

Publications

• Freeman D, Lee A, Price D. Efficacy and safety of tiotropium in COPD patients in primary care--the SPiRiva Usual CarE (SPRUCE) study. Respir Res. 2007 Jul 2;8(1):45. doi: 10.1186/1465-9921-8-45.

Drugs

Indications