%0 Journal Article
%T Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD
%A A-B Tonnel
%A T Perez
%A J-M Grosbois
%A C Verkindre
%J International Journal of COPD
%D 2008
%I Dove Medical Press
%X A-B Tonnel1, T Perez1, J-M Grosbois2, C Verkindre2, M-L Bravo3, M Brun3 on behalf of the TIPHON study groupa1Centre Hospitalier R¨¦gional Universitaire (CHRU) de Lille, Lille Cedex, France; 2Centre Hospitalier de B¨¦thune, B¨¦thune, France; 3Boehringer Ingelheim France, Reims Cedex, France; aSee Appendix: participating investigatorsAbstract: 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 ¦̀g 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 ¡À SD baseline SGRQ total score was 47.4 ¡À 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 ¡À 0.02 L vs 0.01 ¡À 0.02 L; between-group difference: 0.10 ¡À 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
%U http://www.dovepress.com/effect-of-tiotropium-on-health-related-quality-of-life-as-a-primary-ef-a1829