Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD
Authors Tonnel A-B, Perez T, Grosbois J-M, Verkindre C, Bravo M-L, Brun M
Published 6 June 2008 Volume 2008:3(2) Pages 301—310
A-B Tonnel1, T Perez1, J-M Grosbois2, C Verkindre2, M-L Bravo3, M Brun3 on behalf of the TIPHON study groupa
1Centre Hospitalier Régional Universitaire (CHRU) de Lille, Lille Cedex, France; 2Centre Hospitalier de Béthune, Béthune, France; 3Boehringer Ingelheim France, Reims Cedex, France; aSee Appendix: participating investigators
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 µg 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.
Keywords: chronic obstructive pulmonary disease, long-acting anticholinergic, health-related quality of life, tiotropium
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