Publication of the INSPIRE study results

INGELHEIM, Germany, 28  December 2007  - Treatment guidelines recommend tiotropium as a first-line maintenance treatment for patients with all severities of COPD. Inhaled corticosteroids are recommended for patients with severe or very severe COPD and a history of repeated exacerbations.

The primary aim of the INSPIRE study was to compare the relative efficacy of salmeterol and fluticasone propionate (SFC) (Seretide®) and tiotropium (Spiriva®) on exacerbations leading to health care utilisation in patients with severe and very severe chronic obstructive pulmonary disease (COPD) and a history of exacerbations.

The study showed no difference between tiotropium and SFC for the primary endpoint of exacerbations.

Overall safety findings, including overall fatal events, were consistent with a population of patients with severe and very severe COPD.

INSPIRE was powered for the efficacy endpoint, but was not designed as a mortality trial. Patients who did not complete the study were not followed up and there was no independent adjudication of individual fatal cases. No definitive conclusions, therefore, can be drawn from the apparent differences between the two treatment arms.

Spiriva® has a well established efficacy and safety profile in patients with COPD.1 This has been demonstrated by an extensive clinical trial programme, including over 10,000 patients, and almost eight million patients have benefited from Spiriva® since it was first introduced in 2002.2 In addition, the four-year, landmark study Understanding Potential Long-term Impacts on Function with Tiotropium (Uplift®) will report data in 2008.  
 
 
Contact:
Boehringer Ingelheim GmbH
Judith von Gordon
55216  Ingelheim am Rhein
GERMANY
Phone: +49/6132/77 35 82
Fax: +49/6132/77 66 01
E-mail 

References:
1 Kesten S, Jara M, Wentworth C, et al. Pooled clinical trial analysis of tiotropium safety.
2 Data on file. Ingelheim, Germany: Boehringer Ingelheim International GmbH.

Posted: December 2007

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