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Eur Respir J 2003; 22:912-919
Copyright ©ERS Journals Ltd 2003

Maintenance therapy with budesonide and formoterol in chronicobstructive pulmonary disease

P.M. Calverley1, W. Boonsawat2, Z. Cseke3, N. Zhong4, S. Peterson5 and H. Olsson5

1 University Hospital Aintree, Liverpool, UK. 2 Srinagarind Hospital, Khon Kaen University, Thailan., 3 Vas Megyei Markusovszky Kórház, Szombathely, Hungary. 4 Guangzhou Institute of Respiratory Disease, Guangzhou, China, 5 AstraZeneca R&D Lund, Lund, Sweden.

CORRESPONDENCE: P.M. Calverley, Pulmonary and Rehabilitation Research Group, Dept of Medicine, Clinical Sciences, University Hospital Aintree, Longmoor Lane, Liverpool, L9 7AL, UK. Fax: 44 1515295888. E-mail: pmacal@liverpool.ac.uk

Keywords: exacerbations, health-related quality of life, health status, inhaled corticosteroids, long-acting ß2-agonists

Received: March 11, 2003
Accepted July 4, 2003

Lung function in chronic obstructive pulmonary disease (COPD) can be improved acutely by oral corticosteroids and bronchodilators. Whether clinical improvement can be maintained by subsequent inhaled therapy is unknown.

COPD patients (n=1,022, mean prebronchodilator forced expiratory volume in one second (FEV1) 36% predicted) initially received formoterol (9 µg b.i.d.) and oral prednisolone (30 mg o.d.) for 2 weeks. After this time, patients were randomised to b.i.d. inhaled budesonide/formoterol 320/9 µg, budesonide 400 µg, formoterol 9 µg or placebo for 12 months.

Postmedication FEV1 improved by 0.21 L and health-related quality of life using the St George's Respiratory Questionnaire (SGRQ) by 4.5 units after run-in. Fewer patients receiving budesonide/formoterol withdrew from the study than those receiving budesonide, formoterol or placebo. Budesonide/formoterol patients had a prolonged time to first exacerbation (254 versus 96 days) and maintained higher FEV1 (99% versus 87% of baseline), both primary variables versus placebo. They had fewer exacerbations (1.38 versus 1.80 exacerbations per patient per year), had higher prebronchodilator peak expiratory flow, and showed clinically relevant improvements in SGRQ versus placebo (–7.5 units). Budesonide/formoterol was more effective than either monocomponent in both primary variables.

Budesonide/formoterol in a single inhaler (Symbicort®) maintains the benefit of treatment optimisation, stabilising lung function and delaying exacerbations more effectively than either component drug alone or placebo.




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J. F. Donohue
Combination Therapy for Chronic Obstructive Pulmonary Disease: Clinical Aspects
Proceedings of the ATS, November 1, 2005; 2(4): 272 - 281.
[Abstract] [Full Text] [PDF]

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 Proc Am Thorac SocHome page
K. F. Chung
The Role of Airway Smooth Muscle in the Pathogenesis of Airway Wall Remodeling in Chronic Obstructive Pulmonary Disease
Proceedings of the ATS, November 1, 2005; 2(4): 347 - 354.
[Abstract] [Full Text] [PDF]

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 Eur Respir JHome page
J. Haughney, M. R. Partridge, C. Vogelmeier, T. Larsson, R. Kessler, E. Stahl, R. Brice, and C-G. Lofdahl
Exacerbations of COPD: quantifying the patient's perspective using discrete choice modelling
Eur. Respir. J., October 1, 2005; 26(4): 623 - 629.
[Abstract] [Full Text] [PDF]

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 ANN INTERN MEDHome page
D. E. Niewoehner, K. Rice, C. Cote, D. Paulson, J. A. D. Cooper Jr., L. Korducki, C. Cassino, and S. Kesten
Prevention of Exacerbations of Chronic Obstructive Pulmonary Disease with Tiotropium, a Once-Daily Inhaled Anticholinergic Bronchodilator: A Randomized Trial
Ann Intern Med, September 6, 2005; 143(5): 317 - 326.
[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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 Proc Am Thorac SocHome page
T. Higenbottam
Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease: A Case for Treatment
Proceedings of the ATS, April 1, 2005; 2(1): 12 - 19.
[Abstract] [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
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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 Eur Respir JHome page
A.R.L. Medford
Combination therapy with maintenance budesonide and formoterol in COPD
Eur. Respir. J., December 1, 2004; 24(6): 1070 - 1070.
[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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 BMJHome page
W. MacNee
Guidelines for chronic obstructive pulmonary disease
BMJ, August 14, 2004; 329(7462): 361 - 363.
[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
E. Marchand
Withdrawal From and Study Design of the ISOLDE Trial
Chest, August 1, 2004; 126(2): 659 - 659.
[Full Text] [PDF]

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 Am. J. Respir. Crit. Care Med.Home page
P. M. A. Calverley
The GOLD Classification Has Advanced Understanding of COPD
Am. J. Respir. Crit. Care Med., August 1, 2004; 170(3): 211 - 212.
[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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 Eur Respir JHome page
K.F. Rabe and P.J. Sterk
From the Editors
Eur. Respir. J., May 1, 2004; 23(5): 791 - 791.
[Full Text] [PDF]

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 Eur Respir JHome page
P.N.R. Dekhuijzen
Antioxidant properties of N-acetylcysteine: their relevance in relation to chronic obstructive pulmonary disease
Eur. Respir. J., April 1, 2004; 23(4): 629 - 636.
[Abstract] [Full Text] [PDF]


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