Abstract | BACKGROUND: AIMS: To determine whether tiotropium improves lung function/patient-reported outcomes in patients with GOLD stage II COPD naive to maintenance therapy. METHODS: A randomised 24-week double-blind placebo-controlled trial of tiotropium 18 μg once daily (via HandiHaler) was performed in maintenance therapy-naive patients with forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio <0.7 and post- bronchodilator FEV1 ≥50 and <80%. RESULTS: A total of 457 patients were randomised (238 tiotropium, 219 placebo; mean age 62 years; FEV1 1.93 l (66% predicted)). Tiotropium was superior to placebo in mean change from baseline in post-dose FEV1 area under the curve from 0 to 3 h (AUC0-3h) at week 24 (primary endpoint): 0.19 vs. -0.03 l (least-squares mean difference 0.23 l, P<0.001). FVC AUC0-3h, trough and peak FEV1 and FVC were significantly improved with tiotropium versus placebo (P<0.001). Compared with placebo, tiotropium provided numerical improvements in physical activity (P=NS). Physician's Global Assessment (health status) improved (P=0.045) with less impairment on the Work Productivity and Activity Impairment questionnaire (P=0.043) at week 24. The incidence of exacerbations, cough, bronchitis and dyspnoea was lower with tiotropium than placebo. CONCLUSIONS:
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Authors | Thierry Troosters, Frank C Sciurba, Marc Decramer, Nikos M Siafakas, Solomon S Klioze, Santosh C Sutradhar, Idelle M Weisman, Carla Yunis |
Journal | NPJ primary care respiratory medicine
(NPJ Prim Care Respir Med)
Vol. 24
Pg. 14003
(05 20 2014)
ISSN: 2055-1010 [Electronic] England |
PMID | 24841833
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Bronchodilator Agents
- Scopolamine Derivatives
- Tiotropium Bromide
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Topics |
- Activities of Daily Living
- Bronchodilator Agents
(adverse effects, therapeutic use)
- Double-Blind Method
- Female
- Forced Expiratory Volume
- Health Status
- Humans
- Male
- Middle Aged
- Pulmonary Disease, Chronic Obstructive
(drug therapy)
- Scopolamine Derivatives
(adverse effects, therapeutic use)
- Severity of Illness Index
- Tiotropium Bromide
- Treatment Outcome
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