Tiotropium improves FEV1 in patients with COPD irrespective of smoking status

• Type: Article in International Scientific Journal
• Date: 2008

Authors

Moita, J (Author) Other; Barbara, C (Author) Other; Cardoso, J (Author) Other; Costa, R (Author) Other; Sousa, M (Author) Other; Ruiz, J (Author) Other; Santos, ML (Author) Other

Journal

Title: PULMONARY PHARMACOLOGY & THERAPEUTICS

Vol. 21

Pages: 146-151

ISSN: 1094-5539

Indexing

ISI Web of Knowledge - 40 Citations

Scopus - 46 Citations

Other information

Authenticus ID: P-004-4PG

DOI: 10.1016/j.pupt.2007.04.003

Abstract (EN): This study evaluated whether the effect of tiotropium on the change in trough forced expiratory Volume in 1 s (FEV1), vs. placebo, is affected by smoking status. In a 3-month, double-blind Study in 31 centres in Portugal, 311 (289 completed) patients were randomised to tiotropium 18 mu g once daily or placebo. Baseline mean (standard deviation (SD)) FEV1 was 1.11 (0.39) 1 in the tiotropium group and 1.13 (0.39) 1 in the placebo group. Patients had an average smoking history of 55 (25.7) pack-years; 80 (26%) were smokers and 224 (74%) were ex-smokers. The primary end-point was change in morning pre-dose (i.e. trough) FEV1 after 12 weeks. Trough FEV1 at 12 weeks was significantly improved with tiotropium vs. placebo: the difference in means was 102 ml, P = 0.0011 95% confidence interval (0) (41, 164). The difference in means in smokers was 138 ml, P = 0.0105, CI (32, 244); in ex-smokers it was 66 ml, P = 0.0375, Cl (3, 129). The difference between smokers and ex-smokers was not statistically significant (P = 0.6982) and may be due to greater variability and differences in disease severity. The significant improvement in lung function in patients treated with tiotropium vs. placebo in both smokers and ex-smokers suggests that tiotropium is an effective and well-tolerated therapy in chronic obstructive Pulmonary disease (COPD), regardless of smoking status.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 6