Abstract
The aim of the present study was investigate the long-term effect of tiotropium as first maintenance respiratory medication in chronic obstructive pulmonary disease (COPD).
A 4-yr, randomised, multicentre, double-blind, parallel-group, placebo-controlled trial (Understanding Potential Long-term Impacts on Function with Tiotropium (UPLIFT®)) was conducted. Analysis focused on the effect of tiotropium versus matching placebo in the 810 (13.5%) COPD patients not on other maintenance treatment (long-acting β-agonists, inhaled corticosteroids, theophyllines or anticholinergics) at randomisation. Spirometry, health-related quality of life (St George’s Respiratory Questionnaire (SGRQ) score), exacerbations of COPD and mortality were also analysed.
403 patients (mean±sd age 63±8 yrs, post-bronchodilator forced expiratory volume in 1 s (FEV1) 53±12% predicted) received tiotropium and 407 (64±8 yrs of age, post-bronchodilator FEV1 51±12% pred) received placebo. Post-bronchodilator FEV1 decline was 42±4 mL·yr−1 in the tiotropium group and 53±4 mL·yr−1 in the placebo group (p = 0.026). At 48 months, the morning pre-dose FEV1 was 134 mL higher in the tiotropium group compared to the placebo group (p<0.001). SGRQ total score declined more slowly in the tiotropium group (difference of 1.05±0.34 units·yr−1; p = 0.002). This was particularly significant for the impact (difference of 1.08±0.37 units·yr−1; p = 0.004) and activity (1.44±0.40 units·yr−1; p<0.001) domains, but not for symptoms (0.26±0.50 units·yr−1; p = 0.6). At 48 months, the difference in total score was 4.6 units (p<0.001) with tiotropium compared to placebo.
In patients with COPD who are not on maintenance therapy, tiotropium is associated with significant benefits in disease progression.
- Anticholinergic agent
- chronic obstructive pulmonary disease
- disease progression
- exacerbation
- lung function
- quality of life
Footnotes
Support Statement
The study was funded by Boehringer Ingelheim and Pfizer. The design of the trial, monitoring of the trial conduct, approval of the statistical analysis, review of the data, and writing of the manuscript involved a joint advisory committee including D.P. Tashkin, B. Celli, M. Decramer and S. Kesten. T. Troosters reviewed the data and participated in writing of the manuscript. S. Mehra reviewed the data and participated in writing of the manuscript. T. Lystig performed statistical analyses and participated in writing of the manuscript. Collection of the data and the statistical analyses were performed by employees of Boehringer Ingelheim. The decision to submit the manuscript involved all authors. All authors had full access to all of the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.
Clinical Trial
The present study is registered as a clinical trial at ClinicalTrials.gov (NCT00144339) .
Statement of Interest
Statements of interest for all authors of this study, and for the study itself, can be found at www.erj.ersjournals.com/misc/statements.dtl
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