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From Novartis Pharmaceuticals (Dr. Kottakis and Mr. Rapatz), Horsham, UK; the Primary Care Asthma Clinic (Dr. D’Urzo), Toronto, Canada; Hospital General de Agudos "E." Tornu (Dr. De Salvo), Buenos Aires, Argentina; Hospital de Enfermedades Cardiovasculares y del Torax IMSS (Dr. Ramirez-Rivera), Monterrey, Mexico; Hospital Sao Joao, Servico de Pneumologia (Dr. Almeida), Porto, Portugal; and Papanicolaou Hospital, Pneumonological University Clinic (Dr. Sichletidis), Thessaloniki, Greece.
A complete list of participants is located in the Appendix.
Correspondence to: John Kottakis, MD, Novartis HRC, Wimblehurst Rd, Horsham, RH12 5AB, UK; e-mail: ioannis.kottakis{at}pharma.novartis.com
Study objectives: To compare the efficacy of adding formoterol or salbutamol to regular ipratropium bromide treatment in COPD patients whose conditions were suboptimally controlled with ipratropium bromide alone.
Design: A randomized, double-blind, double-dummy, two-period, crossover clinical trial.
Setting: Twenty-four clinics and university medical centers in nine countries.
Patients: One
hundred seventy-two patients with baseline FEV1 
65%
predicted, with FEV1 reversibility to salbutamol not
exceeding the normal variability of the measurement, and symptomatic
despite regular treatment with ipratropium bromide.
Interventions: Each patient received two treatments in random order: either inhaled formoterol dry powder, 12 µg bid, in addition to ipratropium bromide, 40 µg qid for 3 weeks, followed by salbutamol, 200 µg qid, in addition to ipratropium, 40 µg qid for 3 weeks, or vice versa.
Measurements and results: Efficacy end points included morning premedication peak expiratory flow (PEF) during the last week of treatment (primary end point), the area under the curve (AUC) for FEV1 measured for 6 h after morning dose on the last day of treatment, and symptom scores (from daily diary recordings). Morning PEF and the AUC for FEV1 were significantly better for formoterol/ipratropium than for salbutamol/ipratropium (p = 0.0003 and p < 0.0001, respectively). The formoterol/ipratropium combination also induced a greater improvement in mean total symptom scores (p = 0.0042). The safety profile of the two treatments was comparable.
Conclusions: In COPD patients requiring combination bronchodilator treatment, the addition of formoterol to regular ipratropium treatment is more effective than the addition of salbutamol.
Key Words: ß2-agonist • COPD • formoterol • ipratropium • salbutamol
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