Document Detail


Improvements in symptom-limited exercise performance over 8 h with once-daily tiotropium in patients with COPD.
MedLine Citation:
PMID:  16162703     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
STUDY OBJECTIVES: We have previously shown that tiotropium at 18 mug reduces lung hyperinflation and dyspnea during exercise and improves exercise tolerance in patients with COPD. The present study was designed to gain further insight into the duration of improvements.
DESIGN, PATIENTS, AND INTERVENTIONS: A randomized, double-blind, placebo-controlled, parallel-group study was conducted in 261 COPD patients (mean age, 62.5 +/- 7.4 years [+/- SD]; 189 men and 72 women; mean FEV1, 1.2 +/- 0.4 L [43 +/- 12.7% predicted]). On day 0 (first dose), day 21, and day 42 of treatment, pulmonary function tests were performed before and 1 h 20 min after dosing, followed by a constant work rate cycle ergometry test (75% maximum work capacity) to symptom limitation at 2.25 h after dosing. On day 42, an additional constant work rate cycle ergometry test was performed at 8 h after dosing.
RESULTS: Adjusted mean (+/- SE) endurance time (ET) on day 42 was 803 +/- 40 s (tiotropium), vs 568 +/- 42 s (placebo) at 2.25 h after dosing (primary end point; treatment difference, 236 +/- 58 s; p = 0.0001) and 665 +/- 40 s (tiotropium) vs 494 +/- 42 s (placebo) at 8 h after dosing (treatment difference, 171 +/- 58 s; p = 0.0035). Adjusted mean dyspnea intensity at isotime on day 42 was 4.60 +/- 0.16 Borg units (tiotropium), vs 5.65 +/- 0.16 Borg units (placebo) at 2.25 h after dosing (p < 0.001), and 5.54 +/- 0.17 Borg units (tiotropium) vs 6.51 +/- 0.18 Borg units (placebo) at 8 h after dosing (p < 0.001). Adjusted mean pre-exercise inspiratory capacity (IC) on day 42 was 2.41 +/- 0.03 L (tiotropium) vs 2.19 +/- 0.03 L (placebo) at 2.25 h after dosing (p < 0.001), and 2.31 +/- 0.03 L (tiotropium) vs 2.16 +/- 0.03 L (placebo) at 8 h after dosing (p < 0.001). The significant increase in IC with tiotropium compared with placebo was maintained throughout exercise.
CONCLUSIONS: The present study confirms that tiotropium reduces lung hyperinflation at rest and during exercise, reduces exertional dyspnea, and improves symptom-limited exercise tolerance in COPD patients. Furthermore, this study shows that this improvement is present at 2.25 h and at 8 h after dosing after 6 weeks of treatment.
Authors:
François Maltais; Alan Hamilton; Darcy Marciniuk; Paul Hernandez; Frank C Sciurba; Kai Richter; Steven Kesten; Denis O'Donnell
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Chest     Volume:  128     ISSN:  0012-3692     ISO Abbreviation:  Chest     Publication Date:  2005 Sep 
Date Detail:
Created Date:  2005-09-15     Completed Date:  2005-11-08     Revised Date:  2012-09-10    
Medline Journal Info:
Nlm Unique ID:  0231335     Medline TA:  Chest     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1168-78     Citation Subset:  AIM; IM    
Affiliation:
Centre de Recherche, Hôpital Laval, Institut Universitaire de Cardiologie et de Pneumologie de l'Université Laval, 725 Chemin Ste-Foy, Québec, QC, G1V 4G5, Canada. francois.maltais@med.ulaval.ca
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MeSH Terms
Descriptor/Qualifier:
Aged
Bronchodilator Agents / pharmacology*,  therapeutic use
Double-Blind Method
Exercise Test
Exercise Tolerance / drug effects*
Female
Humans
Male
Pulmonary Disease, Chronic Obstructive / drug therapy*
Respiratory Function Tests
Scopolamine Derivatives / pharmacology*,  therapeutic use
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Bronchodilator Agents; 0/Scopolamine Derivatives; 136310-93-5/tiotropium

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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