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Eur Respir J 2003; 21:74-81
Copyright ©ERS Journals Ltd 2003

Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease

W. Szafranski1, A. Cukier2, A. Ramirez3, G. Menga4, R. Sansores5, S. Nahabedian6, S. Peterson7 and H. Olsson7

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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New approaches to COPD
Eur. Respir. Rev., September 1, 2005; 14(94): 2 - 11.
[Abstract] [Full Text] [PDF]

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 Eur Respir JHome page
J. A. van Noord, J-L. Aumann, E. Janssens, J. J. Smeets, J. Verhaert, B. Disse, A. Mueller, and P. J. G. Cornelissen
Comparison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD
Eur. Respir. J., August 1, 2005; 26(2): 214 - 222.
[Abstract] [Full Text] [PDF]

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 Eur Respir JHome page
P. J. Barnes and R. A. Stockley
COPD: current therapeutic interventions and future approaches
Eur. Respir. J., June 1, 2005; 25(6): 1084 - 1106.
[Abstract] [Full Text] [PDF]

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 ThoraxHome page
E F M Wouters, D S Postma, B Fokkens, W C J Hop, J Prins, A F Kuipers, H R Pasma, C A J Hensing, E C Creutzberg, and for the COSMIC (COPD and Seretide: a Multi-Center
Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial
Thorax, June 1, 2005; 60(6): 480 - 487.
[Abstract] [Full Text] [PDF]

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 The Annals of PharmacotherapyHome page
M.-F. Beauchesne, M. Lalande, A. Fillion, and L. Blais
Inhaled corticosteroids and rate of exacerbations in patients with COPD
Ann. Pharmacother., May 1, 2005; 39(5): 973 - 974.
[Full Text] [PDF]

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 Proc Am Thorac SocHome page
R. Buhl and S. G. Farmer
Future Directions in the Pharmacologic Therapy of Chronic Obstructive Pulmonary Disease
Proceedings of the ATS, April 1, 2005; 2(1): 83 - 93.
[Abstract] [Full Text] [PDF]

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 ThoraxHome page
J Vestbo, R Pauwels, J A Anderson, P Jones, P Calverley, and on behalf of the TRISTAN study group
Early onset of effect of salmeterol and fluticasone propionate in chronic obstructive pulmonary disease
Thorax, April 1, 2005; 60(4): 301 - 304.
[Abstract] [Full Text] [PDF]

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 ThoraxHome page
M Decramer, R Gosselink, M Rutten-Van Molken, J Buffels, O Van Schayck, P-A Gevenois, R Pellegrino, E Derom, and W De Backer
Assessment of progression of COPD: report of a workshop held in Leuven, 11-12 March 2004
Thorax, April 1, 2005; 60(4): 335 - 342.
[Abstract] [Full Text] [PDF]

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 ThoraxHome page
M Decramer, R Gosselink, P Bartsch, C-G Lofdahl, W Vincken, R Dekhuijzen, J Vestbo, R Pauwels, R Naeije, and T Troosters
Effect of treatments on the progression of COPD: report of a workshop held in Leuven, 11-12 March 2004
Thorax, April 1, 2005; 60(4): 343 - 349.
[Abstract] [Full Text] [PDF]

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 BMJHome page
C B Cooper and D P Tashkin
Recent developments in inhaled therapy in stable chronic obstructive pulmonary disease
BMJ, March 19, 2005; 330(7492): 640 - 644.
[Full Text] [PDF]

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 ThoraxHome page
C E Brightling, S McKenna, B Hargadon, S Birring, R Green, R Siva, M Berry, D Parker, W Monteiro, I D Pavord, et al.
Sputum eosinophilia and the short term response to inhaled mometasone in chronic obstructive pulmonary disease
Thorax, March 1, 2005; 60(3): 193 - 198.
[Abstract] [Full Text] [PDF]

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 Eur Respir JHome page
P.M.A. Calverley
From the author
Eur. Respir. J., December 1, 2004; 24(6): 1070 - 1071.
[Full Text] [PDF]

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 Proc Am Thorac SocHome page
J. F. Donohue and J. A. Ohar
Effects of Corticosteroids on Lung Function in Asthma and Chronic Obstructive Pulmonary Disease
Proceedings of the ATS, November 1, 2004; 1(3): 152 - 160.
[Abstract] [Full Text] [PDF]

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 Proc Am Thorac SocHome page
P. M. A. Calverley
Effect of Corticosteroids on Exacerbations of Asthma and Chronic Obstructive Pulmonary Disease
Proceedings of the ATS, November 1, 2004; 1(3): 161 - 166.
[Abstract] [Full Text] [PDF]

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 Proc Am Thorac SocHome page
P. W. Jones
Clinical Effects of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease
Proceedings of the ATS, November 1, 2004; 1(3): 167 - 170.
[Abstract] [Full Text] [PDF]

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 Proc Am Thorac SocHome page
M. Johnson
Interactions between Corticosteroids and {beta}2-Agonists in Asthma and Chronic Obstructive Pulmonary Disease
Proceedings of the ATS, November 1, 2004; 1(3): 200 - 206.
[Abstract] [Full Text] [PDF]

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 ChestHome page
D. A. Mahler, S. Huang, M. Tabrizi, and G. M. Bell
Efficacy and Safety of a Monoclonal Antibody Recognizing Interleukin-8 in COPD: A Pilot Study
Chest, September 1, 2004; 126(3): 926 - 934.
[Abstract] [Full Text] [PDF]

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 Eur Respir JHome page
The TORCH Study Group
The TORCH (TOwards a Revolution in COPD Health) survival study protocol
Eur. Respir. J., August 1, 2004; 24(2): 206 - 210.
[Abstract] [Full Text] [PDF]

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 ChestHome page
F. A. El-Kassimi and N. A. Hanania
Differentiating Asthma and COPD Patients
Chest, August 1, 2004; 126(2): 653 - 655.
[Full Text] [PDF]

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 ChestHome page
D. W. Mapel
Treatment Implications on Morbidity and Mortality in COPD
Chest, August 1, 2004; 126(2_suppl_1): 150S - 158S.
[Abstract] [Full Text] [PDF]

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 ChestHome page
M. Cazzola and R. Dahl
Inhaled Combination Therapy With Long-Acting {beta}2-Agonists and Corticosteroids in Stable COPD
Chest, July 1, 2004; 126(1): 220 - 237.
[Abstract] [Full Text] [PDF]

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 NEJMHome page
E. R. Sutherland and R. M. Cherniack
Management of Chronic Obstructive Pulmonary Disease
N. Engl. J. Med., June 24, 2004; 350(26): 2689 - 2697.
[Full Text] [PDF]

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 Eur Respir JHome page
B.R. Celli, W. MacNee, A. Agusti, A. Anzueto, B. Berg, A.S. Buist, P.M.A. Calverley, N. Chavannes, T. Dillard, B. Fahy, et al.
Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper
Eur. Respir. J., June 1, 2004; 23(6): 932 - 946.
[Full Text] [PDF]

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 ThoraxHome page
D L Hahn, P S Burge, and S A Lewis
Ethics of placebo controlled studies of inhaled steroids for COPD * Authors' reply
Thorax, June 1, 2004; 59(6): 539 - 540.
[Full Text] [PDF]

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 Eur Respir JHome page
S. Spencer, P.M.A. Calverley, P.S. Burge, and P.W. Jones
Impact of preventing exacerbations on deterioration of health status in COPD
Eur. Respir. J., May 1, 2004; 23(5): 698 - 702.
[Abstract] [Full Text] [PDF]


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