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Clinical Investigations: COPD |

In 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

Anthony D. D’Urzo, MD; Mariá Cristina De Salvo, MD; Alicia Ramirez-Rivera, MD; Joâo Almeida, MD; Lazaros Sichletidis, MD, FCCP; Guenter Rapatz, MSc; John Kottakis, MD; for the FOR-INT-03 Study Group
Author and Funding Information

Affiliations: *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@pharma.novartis.com



Chest. 2001;119(5):1347-1356. doi:10.1378/chest.119.5.1347
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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.

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