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Bronchodilator responsiveness and onset of effect with budesonide/formoterol pMDI in COPD.
- Source :
-
Respiratory medicine [Respir Med] 2011 Aug; Vol. 105 (8), pp. 1176-88. Date of Electronic Publication: 2011 Apr 30. - Publication Year :
- 2011
-
Abstract
- Background: Chronic obstructive pulmonary disease (COPD) patients are thought to have limited bronchodilator response, determined by changes in forced expiratory volume in 1s (FEV(1)). In this study, we assessed bronchodilator response in patients with COPD using not only FEV(1) but also changes in lung volume expressed as forced vital capacity (FVC) and inspiratory capacity (IC). We also evaluated the speed of onset of bronchodilation.<br />Methods: Data were from 2 randomized, double-blind, placebo-controlled studies (6-months [NCT00206154]; 12-months [NCT00206167]) in patients with moderate to very severe COPD.<br />Treatments: twice daily budesonide/formoterol pressurized metered-dose inhaler (pMDI) 320/9μg, budesonide/formoterol pMDI 160/9μg, formoterol dry powder inhaler (DPI) 9μg, placebo.<br />Results: The percentage of patients with FEV(1) improvement (≥12% and ≥200mL; American Thoracic Society [ATS] criterion) was 34-39% post-albuterol (screening). On day of randomization (DOR), a larger proportion receiving formoterol-containing treatment exhibited reversibility within 60min: FEV(1) (57-59%). Similar results were seen for IC (50-61%) and FVC (57-67%) using the same improvement criteria. The time to ≥15% FEV(1) improvement on DOR was 5.0, 4.8, and 7.3min for budesonide/formoterol 320/9, budesonide/formoterol 160/9, and formoterol, respectively. Time to ≥15% FEV(1) improvement was better maintained with budesonide/formoterol than formoterol at treatment end (6 and 12 months).<br />Conclusions: Most patients with moderate to very severe COPD exhibit ATS-defined bronchodilator reversibility based on flow and lung volume measures after budesonide/formoterol pMDI or formoterol treatment. Budesonide/formoterol pMDI also has a rapid (within 5min) onset of bronchodilation that is maintained over time compared with formoterol alone.<br /> (Copyright © 2011. Published by Elsevier Ltd.)
- Subjects :
- Administration, Inhalation
Adult
Aged
Aged, 80 and over
Dose-Response Relationship, Drug
Double-Blind Method
Female
Forced Expiratory Volume drug effects
Forced Expiratory Volume physiology
Formoterol Fumarate
Humans
Male
Middle Aged
Pulmonary Disease, Chronic Obstructive physiopathology
Spirometry methods
Vital Capacity drug effects
Vital Capacity physiology
Bronchodilator Agents therapeutic use
Budesonide therapeutic use
Ethanolamines therapeutic use
Pulmonary Disease, Chronic Obstructive drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1532-3064
- Volume :
- 105
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Respiratory medicine
- Publication Type :
- Academic Journal
- Accession number :
- 21531124
- Full Text :
- https://doi.org/10.1016/j.rmed.2011.02.020