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1 Dept Lung Diseases, Voivodeship Specialist Hospital, Radom, Poland. 2 Division of Respiratory Diseases, Hospital das Clinicas, University of Sao Paulo, Sao Paulo, Brazil. 3 Hospital de Enfermedades Cardiovasculares y del Tórax, Monterrey, Mexico. 4 Pneumology Dept, Hospital Maria Ferrer, Buenos Aires, Argentina. 5 Dept of Research in Tobacco Smoking and COPD, Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico. 6 Hospital Evita Lanus, Buenos Aires, Argentina. 7 AstraZeneca R&D, Lund, Sweden
CORRESPONDENCE: H. Olsson, AstraZeneca R&D Lund, SE-22187, Lund, Sweden. Fax: 46 46336303. E-mail: Hakan.HOL.Olsson@astrazeneca.com
Keywords: budesonide, budesonide/formoterol, chronic obstructive pulmonary disease, exacerbations, formoterol
Received: April 16, 2002
Accepted August 5, 2002
This study was supported by AstraZeneca.
The efficacy and safety of budesonide/formoterol in a single inhaler compared with placebo, budesonide and formoterol were evaluated in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
In a 12-month, randomised, double-blind, placebo-controlled, parallel-group study in 812 adults (mean age 64 yrs, mean forced expiratory volume in one second (FEV1) 36% predicted normal), patients received two inhalations twice daily of either budesonide/formoterol (Symbicort®) 160/4.5 µg (delivered dose), budesonide 200 µg (metered dose), formoterol 4.5 µg or placebo. Severe exacerbations and FEV1 (primary variables), peak expiratory flow (PEF), COPD symptoms, health-related quality of life (HRQL), mild exacerbations, use of reliever ß2-agonist and safety variables were recorded.
Budesonide/formoterol reduced the mean number of severe exacerbations per patient per year by 24% versus placebo and 23% versus formoterol. FEV1 increased by 15% versus placebo and 9% versus budesonide. Morning PEF improved significantly on day 1 versus placebo and budesonide; after 1 week, morning PEF was improved versus placebo, budesonide and formoterol. Improvements in morning and evening PEF versus comparators were maintained over 12 months. Budesonide/formoterol decreased all symptom scores and use of reliever ß2-agonists significantly versus placebo and budesonide, and improved HRQL versus placebo. All treatments were well tolerated.
These results suggest a role for budesonide/formoterol in the long-term management of moderate-to-severe chronic obstructive pulmonary disease.
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