Formoterol monotherapy compared with combined ipratropium bromide plus fenoterol in the treatment of chronic obstructive pulmonary disease

Objectives: To compare the efficacy and tolerability of formoterol (12 or 2 4 mug 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 Germ an centres. Patients: 101 patients with COPD. Interventions: The patients were randomised to receive either formoterol 12 mug twice daily or a combination of ipratropium bromide 20 mug plus fenote rol 50 mug three times daily for 4 weeks. Dosages could be doubled if requi red. Results: Morning pre-dose airway resistance (R-eff) decreased significantly from 0.87 to 0.66 kPa .L-1.s with formoterol and from 0.81 to 0.66 kPa .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 oc curred in 7/52 (13.5%) of the formoterol and 11/49 (22.4%) of the combinati on 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 tha t of combined ipratropium bromide and fenoterol in the treatment of COPD. F ormoterol had a better adverse event profile and a lower rate of discontinu ations resulting from adverse events.