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

Welte, Tobias; Miravitlles, Marc; Hernandez, Paul; Eriksson, Göran LU ; Peterson, Stefan; Polanowski, Tomasz and Kessler, Romain (2009) In American Journal of Respiratory and Critical Care Medicine 180(8). p.741-750
Abstract
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 beta(2)-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 (118 mu g once daily) plus either budesonide/formoterol (320/9 mu g) (n = 329) or placebo (n = 331) twice daily.... (More)
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 beta(2)-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 (118 mu g once daily) plus either budesonide/formoterol (320/9 mu g) (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). (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
tiotropium, exacerbations, morning activities, morning symptoms, budesonide/formoterol
in
American Journal of Respiratory and Critical Care Medicine
volume
180
issue
8
pages
741 - 750
publisher
Am Thoracic Soc
external identifiers
  • wos:000270743100008
  • scopus:70349854706
ISSN
1535-4970
DOI
10.1164/rccm.200904-0492OC
language
English
LU publication?
yes
id
5dd872b7-6a6d-4775-a8fb-8db1dba68446 (old id 1507662)
date added to LUP
2009-11-19 16:09:53
date last changed
2017-12-10 03:42:59
@article{5dd872b7-6a6d-4775-a8fb-8db1dba68446,
  abstract     = {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 beta(2)-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 (118 mu g once daily) plus either budesonide/formoterol (320/9 mu g) (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 &lt; 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 &lt; 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).},
  author       = {Welte, Tobias and Miravitlles, Marc and Hernandez, Paul and Eriksson, Göran and Peterson, Stefan and Polanowski, Tomasz and Kessler, Romain},
  issn         = {1535-4970},
  keyword      = {tiotropium,exacerbations,morning activities,morning symptoms,budesonide/formoterol},
  language     = {eng},
  number       = {8},
  pages        = {741--750},
  publisher    = {Am Thoracic Soc},
  series       = {American Journal of Respiratory and Critical Care Medicine},
  title        = {Efficacy and Tolerability of Budesonide/Formoterol Added to Tiotropium in Patients with Chronic Obstructive Pulmonary Disease},
  url          = {http://dx.doi.org/10.1164/rccm.200904-0492OC},
  volume       = {180},
  year         = {2009},
}