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Clinical InvestigationsCOPDIn Patients With COPD, Treatment With a Combination of Formoterol and Ipratropium Is More Effective Than a Combination of Salbutamol and Ipratropium: A 3-Week, Randomized, Double-Blind, Within-Patient, Multicenter Study
Section snippets
Study Design
This was a randomized, multicenter, double-blind, double-dummy, two-period, crossover clinical trial comparing the clinical benefits of adding either formoterol (Foradil Aerolizer; Novartis; Basel, Switzerland), 12 μg bid via dry-powder inhaler, or salbutamol (Ventolin; Glaxo Smith Kline; Uxbridge, UK), 200 μg qid via pressurized metered-dose inhaler (100 μg/puff), to ipratropium bromide (Atrovent; Boehringer Ingelheim; Ingelheim, Germany), 40 μg qid via pressurized metered-dose inhaler (20
Study Patients
A total of 252 patients were screened, and 172 patients were randomized to each treatment sequence as reported in Table 1. Of the randomized patients, 159 completed the study and 13 withdrew prematurely, all during the first treatment period. Four patients were discontinued due to adverse events, and all these discontinuations occurred during treatment with the salbutamol/ipratropium combination. Four patients withdrew their consent, two patients were unavailable for follow-up, two patients
Discussion
The results of this randomized, double-blind, crossover study indicate that the addition of formoterol, 12 μg bid, to treatment with ipratropium bromide, 40 μg qid, is more effective than the addition of salbutamol, 200 μg qid, in patients with COPD who require combined bronchodilator therapy.
Mean morning premedication PEF increased significantly more during treatment with formoterol/ipratropium than during treatment with salbutamol/ipratropium. The change from baseline in the ITT-1 population,
Appendix
Participants: J. Almeida, MD, Porto, Portugal; S. Boucher, MD, Quebec, Canada; J. Castillo, MD, Sevilla, Spain; S. Centanni, MD, Milano, Italy; J. Cordoso, MD, Lisbon, Portugal; M. C. De Salvo, MD, Buenos Aires, Argentina; C. G. Di Bartolo, MD, Buenos Aires, Argentina; A. D'Urzo, MD, Toronto, Canada; A. Eivindson, MD, Arendal, Norway; D. Gorecka, MD, Warsaw, Poland; C. Gratziou, MD, Athens, Greece; J. Kottakis, MD, Horsham, UK; J. Kozielski, MD, Zabrze, Poland; G. Krammer, MSc, Basel,
ACKNOWLEDGMENT
We are grateful to Professor Paul W. Jones for the QoL results.
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Cited by (0)
This study was supported by a research grant from Novartis Pharma A.G., Basel, Switzerland. According to their statements, the authors and all study investigators have not made any financial arrangement whereby the value of the compensation could be influenced by the outcome of the study; have not received significant payments from the sponsor of other sorts, excluding the costs for conducting the study; do not have a proprietary or financial interest in
the test product such as patent, trademark, copyright, or licensing agreements; do not hold a significant equity interest in the sponsor of the study (exceeding $50,000 [US]). John Kottakis, MD, and Guenter Rapatz, MSc, hold permanent positions with Novartis Pharmaceuticals.
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A complete list of participants is located in the Appendix