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Budesonide added to formoterol contributes to improved exercise tolerance in patients with COPD.
- Source :
-
Respiratory medicine [Respir Med] 2010 Oct; Vol. 104 (10), pp. 1450-9. Date of Electronic Publication: 2010 Aug 07. - Publication Year :
- 2010
-
Abstract
- Background: Breathlessness and exercise intolerance frequently impact the daily life of patients with COPD.<br />Methods: This double-blind, multicentre, three-period crossover study randomised 111 patients with COPD (mean age 64 years, mean FEV(1) 38% of predicted normal) to budesonide/formoterol 320/9 microg, formoterol 9 microg or placebo, twice daily for 1 week, following a 1-week run-in period with 1-week wash-out between treatments. Terbutaline (0.5 mg/dose) was used as needed. The primary efficacy variable was exercise endurance time (EET) at 75% peak work capacity with cycle ergometry assessed 1 h post-morning dose.<br />Results: Budesonide/formoterol prolonged EET 1 h post-morning dose versus formoterol by 69 s (P < 0.005) and placebo by 105 s (P < 0.0001) and improved inspiratory capacity (IC) at isotime during exercise versus formoterol by 8% (P = 0.011) and placebo by 16% (P < 0.0001). Borg score at isotime was reduced by 0.48 (P = 0.12) and 0.78 (P = 0.014) compared with formoterol and placebo, respectively. At the repeated cycle test 6 h after morning dose, the effect on EET still favoured budesonide/formoterol over formoterol and placebo, while the isotime IC and Borg score were similar but better than placebo for the active study drugs. Budesonide/formoterol and formoterol improved health status (St George's Respiratory Questionnaire total score: mean difference versus placebo -2.4 and -2.2, respectively). All treatments were well tolerated.<br />Conclusions: Budesonide/formoterol resulted in a significant improvement in endurance time 1 h after the last morning dose in a 1-week treatment period versus formoterol and placebo. This study demonstrates, for the first time, the benefit of inhaled corticosteroids in addition to long-acting beta(2)-agonists on exercise tolerance in COPD patients. www.clinicaltrials.gov registration number: NCT00489853.
- Subjects :
- Administration, Inhalation
Adult
Aged
Aged, 80 and over
Cross-Over Studies
Double-Blind Method
Drug Therapy, Combination methods
Dyspnea physiopathology
Exercise Test
Exercise Tolerance physiology
Female
Forced Expiratory Volume drug effects
Forced Expiratory Volume physiology
Formoterol Fumarate
Humans
Male
Middle Aged
Pulmonary Disease, Chronic Obstructive physiopathology
Surveys and Questionnaires
Treatment Outcome
Bronchodilator Agents administration & dosage
Budesonide administration & dosage
Dyspnea drug therapy
Ethanolamines administration & dosage
Exercise Tolerance drug effects
Pulmonary Disease, Chronic Obstructive drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1532-3064
- Volume :
- 104
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Respiratory medicine
- Publication Type :
- Academic Journal
- Accession number :
- 20692140
- Full Text :
- https://doi.org/10.1016/j.rmed.2010.07.006