Formoterol Monotherapy Compared with Combined Ipratropium Bromide plus Fenoterol in the Treatment of Chronic Obstructive Pulmonary Disease

摘要

Objectives: To compare the efficacy and tolerability of formoterol (12 or 24mug twice daily) alone with combined ipratropium bromide and fenoterol in the treatment of chronic obstructive pulmonary disease (COPD).Design and Setting: Randomised, parallel-group, open-label study in 10 German centres.Patients: 101 patients with COPD.Interventions: The patients were randomised to receive either formoterol 12mug twice daily or a combination of ipratropium bromide 20mug plus fenoterol 50mug three times daily for 4 weeks. Dosages could be doubled if required.Results: Morning pre-dose airway resistance (R_(eff)) decreasedsignificantlyfrom 0.87 to 0.66 kP_a·L~(-1)·s with formoterol and from 0.81 to 0.66 kP_a·L~(-1)·s with combined ipratropium bromide and fenoterol (p = ns). The treatment groups were similar with respect to other lung function parameters, daily clinical symptom scores and salbutamol rescue medication. Adverse events occurred in 7/52 (13.5%) of the formoterol and 11/49 (22.4%) of the combination therapy group, and were the reason for study discontinuation in one (1.9%) versus seven (14.3%) patients. The overall discontinuation rate was 5.8% (3/52) with formoterol and 20.4% (10/49) with ipratropium bromide/fenoterol (p = 0.038).Conclusions: The efficacy of formoterol monotherapy was comparable with that of combined ipratropium bromide and fenoterol in the treatment of COPD. Formoterol had a better adverse event profile and a lower rate of discontinuations resulting from adverse events.