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Randomized Controlled Trial
. 2008;3(2):301-10.
doi: 10.2147/copd.s2463.

Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD

A-B Tonnel  1 , T Perez, J-M Grosbois, C Verkindre, M-L Bravo, M Brun; TIPHON study group
Collaborators, Affiliations
Randomized Controlled Trial

Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD

A-B Tonnel et al. Int J Chron Obstruct Pulmon Dis. 2008.

Abstract

Clinical manifestations of chronic obstructive pulmonary disease (COPD), including airflow limitation, dyspnea, and activity limitation, ultimately lead to impaired health-related quality of life (HRQoL). This 9-month, randomized, double-blind, multicenter study compared the effect of once-daily tiotropium 18 microg and placebo on HRQoL, spirometric parameters, and exacerbations in 554 patients with moderate-to-severe COPD. HRQoL was assessed using the St. George's Respiratory Questionnaire (SGRQ) and the new 8-item Visual Simplified Respiratory Questionnaire (VSRQ), which is currently being validated. The primary efficacy endpoint was the proportion of patients achieving a reduction of at least 4 units in the SGRQ total score at study end (Month 9). Mean +/- SD baseline SGRQ total score was 47.4 +/- 18.1. Significantly more tiotropium-treated patients achieved a reduction of at least 4 units in the SGRQ score vs placebo at study end (59.1% vs 48.2%, respectively; p = 0.029). Tiotropium significantly improved spirometric parameters (forced expiratory volume in 1 second [FEV1]: 0.11 +/- 0.02 L vs 0.01 +/- 0.02 L; between-group difference: 0.10 +/- 0.03 L, p = 0.0001) and reduced exacerbations vs placebo. Maintenance treatment with tiotropium provided significant and clinically relevant improvements in HRQoL, as measured by the SGRQ.

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Figures

Figure 1
Figure 1
Trial flow chart.
Figure 2
Figure 2
Percentage of responders (proportion of patients with at least 4 units improvement in SGRQ total score during the 9-month study).
Figure 3
Figure 3
Adjusted mean (SE) change from baseline in SGRQ scores in patients taking tiotropium or placebo: a) change in total score during the 9-month study; and b) change in domain scores at study end (means adjusted for baseline SGRQ scores).
Figure 4
Figure 4
Adjusted mean (SE) change from baseline in spirometric parameters at study end (means adjusted for baseline values).
See this image and copyright information in PMC

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