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Published ahead of print on July 30, 2009, doi:10.1164/rccm.200904-0492OC
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American Journal of Respiratory and Critical Care Medicine Vol 180. pp. 741-750, (2009)
© 2009 American Thoracic Society
doi: 10.1164/rccm.200904-0492OC

Original Article

Efficacy and Tolerability of Budesonide/Formoterol Added to Tiotropium in Patients with Chronic Obstructive Pulmonary Disease

Tobias Welte1, Marc Miravitlles2, Paul Hernandez3, Göran Eriksson4,5, Stefan Peterson5, Tomasz Polanowski5 and Romain Kessler6

1 Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany; 2 Fundació Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain; 3 Respirology Division, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; 4 Department of Respiratory Medicine and Allergology, University Hospital, Lund, Sweden; 5 AstraZeneca Research and Development, Lund, Sweden; and 6 Department of Pneumology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France

Correspondence and requests for reprints should be addressed to Tobias Welte, M.D., Head of Respiratory Medicine, Department of Respiratory Medicine, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany. E-mail: Welte.Tobias{at}MH-Hannover.DE

Rationale: Budesonide/formoterol and tiotropium are commonly used maintenance treatments for patients with chronic obstructive pulmonary disease. Combining these medications may provide additional benefits.

Objectives: To assess the efficacy and tolerability of budesonide/formoterol added to tiotropium in patients eligible for inhaled corticosteroid/long-acting β2-agonist combination therapy.

Methods: In this 12-week, randomized, double-blind, parallel-group, multicenter study, after a 2-week run-in, 660 subjects (75% male; mean age, 62 yr; FEV1, 1.1 L; 38% predicted normal), 40 years of age or older, received tiotropium (18 µg once daily) plus either budesonide/formoterol (320/9 µg) (n = 329) or placebo (n = 331) twice daily.

Measurements and Main Results: Clinic predose (primary outcome) and postdose FEV1, predose and postdose forced vital capacity and inspiratory capacity, and health status were measured. Other outcomes included daily measurements taken at home (pre- and postdose morning FEV1 and peak expiratory flow, morning symptoms and activities, and morning reliever use), severe exacerbations, and tolerability. Over the treatment period, budesonide/formoterol plus tiotropium significantly increased predose FEV1 by 6% (65 ml) and postdose by 11% (123 and 131 ml at 5 and 60 min postdose, respectively) versus tiotropium alone (both P < 0.001). Other outcomes all significantly improved with budesonide/formoterol plus tiotropium versus tiotropium alone. The number of severe exacerbations decreased by 62% (rate ratio, 0.38; 95% confidence interval, 0.25–0.57; P < 0.001). Both treatments were well tolerated.

Conclusions: In patients with chronic obstructive pulmonary disease, budesonide/formoterol added to tiotropium versus tiotropium alone provides rapid and sustained improvements in lung function, health status, morning symptoms and activities, and reduces severe exacerbations.

Clinical trial registered with www.clinicaltrials.gov (NCT00496470).

Key Words: morning activities • morning symptoms • exacerbations • tiotropium • budesonide/formoterol


AT A GLANCE COMMENTARY

Scientific Knowledge on the Subject
Evidence from clinical trials indicates that combining an anticholinergic with an inhaled corticosteroid (ICS) and a long-acting β2-agonist (LABA) may provide clinical benefits additional to those associated with these treatments alone in patients with chronic obstructive pulmonary disease (COPD). However, to date, no studies have specifically investigated the therapeutic benefits of tiotropium combined with budesonide/formoterol.

What This Study Adds to the Field
Budesonide/formoterol added to tiotropium compared with tiotropium alone was shown to improve overall lung function and daytime and nighttime symptoms and reduce severe exacerbations in patients with COPD eligible for ICS/LABA combination therapy. Significant improvements were also seen in morning lung function, morning symptoms and reliever use, and patients' ability to perform morning activities. This study thus highlights the use of a triple-therapy approach with budesonide/formoterol added to tiotropium in the management of patients with COPD.

 

Related articles in AJRCCM:

Triple Therapy for Chronic Obstructive Pulmonary Disease: Trials Catching Up with Clinical Practice?
Paul W. Jones
AJRCCM 2009 180: 689-690. [Full Text]  



This article has been cited by other articles:


Home page
 Am. J. Respir. Crit. Care Med.Home page
P. W. Jones
Triple Therapy for Chronic Obstructive Pulmonary Disease: Trials Catching Up with Clinical Practice?
Am. J. Respir. Crit. Care Med., October 15, 2009; 180(8): 689 - 690.
[Full Text] [PDF]


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