Table 1 Patient inclusion and exclusion criteria

From: Tiotropium in patients with moderate COPD naive to maintenance therapy: a randomised placebo-controlled trial

Inclusion criteria

Exclusion criteria

Male or female

Age 40–80 years

Smoking history ≥10 pack-years

Diagnosis of COPD (GOLD stage II): post-bronchodilator FEV1/FVC ratio <0.7); FEV1 ≥50 and <80% of predicted normal; MRC dyspnoea score ≥2

Ability to: demonstrate compliance with HandiHaler, a salbutamol MDI, and the activity monitor; perform acceptable PFTs; an exercise stress test; follow study procedures

Prior maintenance medication (LABAs, inhaled or systemic corticosteroids, theophylline, leukotriene receptor antagonists) within six months prior to screening

Current chronic treatment with systemic steroids

Diagnosis of asthma

History of cystic fibrosis

Upper and/or lower respiratory tract infection or COPD exacerbation in six weeks prior to, or during, screening

  1. Abbreviations: COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; GOLD, Global Initiative for Chronic Obstructive Lung Disease; LABA, long-acting β2-agonist; MDI, metered-dose inhaler; MRC, Medical Research Council; PFTs, pulmonary function tests.
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