Published in:
01-04-2001 | Clinical Use
Formoterol Monotherapy Compared with Combined Ipratropium Bromide plus Fenoterol in the Treatment of Chronic Obstructive Pulmonary Disease
Authors:
Pd Dr Martin Konermann, Rainer Suchantke, Jürgen Mogck, Jens Brauburger, Matthias Bräutigam
Published in:
Clinical Drug Investigation
|
Issue 4/2001
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Abstract
Objectives
To compare the efficacy and tolerability of formoterol (12 or 24μg 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 12μg twice daily or a combination of ipratropium bromide 20μg plus fenoterol 50μg three times daily for 4 weeks. Dosages could be doubled if required.
Results
Morning pre-dose airway resistance (Reff) 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 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.