title: Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD.
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.
authors.affiliation: Centre Hospitalier Régional Universitaire (CHRU) de Lille, Service de Pneumologie et Immuno-Allergologie, Lille Cedex, France. ab-tonnel@chru-lille.fr
authors.forename: A-B
authors.initials: AB
authors.lastname: Tonnel
authors.forename: T
authors.initials: T
authors.lastname: Perez
authors.forename: J-M
authors.initials: JM
authors.lastname: Grosbois
authors.forename: C
authors.initials: C
authors.lastname: Verkindre
authors.forename: M-L
authors.initials: ML
authors.lastname: Bravo
authors.forename: M
authors.initials: M
authors.lastname: Brun
mesh_terms: D018680:Cholinergic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005540:Forced Expiratory Flow Rates / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D011788:Quality of Life; D012189:Retrospective Studies; D012602:Scopolamine Derivatives / Q000008:administration & dosage / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D013997:Time Factors; D000069447:Tiotropium Bromide; D016896:Treatment Outcome
chemical_list: D018680:Cholinergic Antagonists; D003692:Delayed-Action Preparations; D012602:Scopolamine Derivatives; D000069447:Tiotropium Bromide