Experience of long-term treatment with tiotropium bromide of patients with chronic obstructive pulmonary disease

Abstract

This one year open randomized comparative trial was designed to evaluate efficacy of tiotropium bromide (TB) in disabled patients with mild to moderate chronic obstructive pulmonary disease (COPD). The patients were Ј 60 years old. The TB group patients (n = 46) received Spiriva (Boehringer Ingelheim, Germany) 18 mg daily, the F group patients (n = 29) received Foradil (Novartis Pharma AG, Switzerland) 12 mg b.i.d. for a year. The active control group (AC, n = 14) were given inhaled steroids and short acting b2 agonists as before entering the trial. We assessed lung function using spirometry, the annual decline of FEV1, severity of dyspnea using Baseline and Transitional Dyspnea Indexes, rate and length of exac erbations, and quality of life (QoL) using the St.George's Respiratory Questionnaire. The trial was close to real life practice. Results demonstrated efficacy of both TB and F in therapy of disabled COPD patients compared with the AC group. Criteria of efficacy of long term TB administration were slowing of the annual FEV1 decline, improvement of dyspnea, reduction in number of exacerbations, and improvement of QoL in TB and F patients compared with the baseline.