Bronchodilator responsiveness and onset of effect with budesonide/ formoterol pMDI in COPD

Bartolome R. Celli, Donald P. Tashkin, Stephen Israel Rennard, Jennifer McElhattan, Ubaldo J. Martin

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Background: Chronic obstructive pulmonary disease (COPD) patients are thought to have limited bronchodilator response, determined by changes in forced expiratory volume in 1 s (FEV1). In this study, we assessed bronchodilator response in patients with COPD using not only FEV1 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. 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. Treatments: twice daily budesonide/formoterol pressurized metered-dose inhaler (pMDI) 320/9 μg, budesonide/formoterol pMDI 160/9 μg, formoterol dry powder inhaler (DPI) 9 μg, placebo. Results: The percentage of patients with FEV1 improvement (≥12% and ≥200 mL; 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 60 min: FEV1 (57-59%). Similar results were seen for IC (50-61%) and FVC (57-67%) using the same improvement criteria. The time to ≥15% FEV1 improvement on DOR was 5.0, 4.8, and 7.3 min for budesonide/formoterol 320/9, budesonide/formoterol 160/9, and formoterol, respectively. Time to ≥15% FEV1 improvement was better maintained with budesonide/formoterol than formoterol at treatment end (6 and 12 months). 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 5 min) onset of bronchodilation that is maintained over time compared with formoterol alone.

Original languageEnglish (US)
Pages (from-to)1176-1188
Number of pages13
JournalRespiratory Medicine
Volume105
Issue number8
DOIs
StatePublished - Aug 1 2011

Fingerprint

Metered Dose Inhalers
Budesonide
Bronchodilator Agents
Chronic Obstructive Pulmonary Disease
Forced Expiratory Volume
Inspiratory Capacity
Vital Capacity
Random Allocation
Formoterol Fumarate
Placebos
Dry Powder Inhalers
Lung
Albuterol
Therapeutics

Keywords

  • Bronchodilation
  • COPD
  • Lung volume
  • Onset of effect
  • Reversibility
  • Treatment

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Celli, B. R., Tashkin, D. P., Rennard, S. I., McElhattan, J., & Martin, U. J. (2011). Bronchodilator responsiveness and onset of effect with budesonide/ formoterol pMDI in COPD. Respiratory Medicine, 105(8), 1176-1188. https://doi.org/10.1016/j.rmed.2011.02.020

Bronchodilator responsiveness and onset of effect with budesonide/ formoterol pMDI in COPD. / Celli, Bartolome R.; Tashkin, Donald P.; Rennard, Stephen Israel; McElhattan, Jennifer; Martin, Ubaldo J.

In: Respiratory Medicine, Vol. 105, No. 8, 01.08.2011, p. 1176-1188.

Research output: Contribution to journalArticle

Celli, BR, Tashkin, DP, Rennard, SI, McElhattan, J & Martin, UJ 2011, 'Bronchodilator responsiveness and onset of effect with budesonide/ formoterol pMDI in COPD', Respiratory Medicine, vol. 105, no. 8, pp. 1176-1188. https://doi.org/10.1016/j.rmed.2011.02.020
Celli, Bartolome R. ; Tashkin, Donald P. ; Rennard, Stephen Israel ; McElhattan, Jennifer ; Martin, Ubaldo J. / Bronchodilator responsiveness and onset of effect with budesonide/ formoterol pMDI in COPD. In: Respiratory Medicine. 2011 ; Vol. 105, No. 8. pp. 1176-1188.
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abstract = "Background: Chronic obstructive pulmonary disease (COPD) patients are thought to have limited bronchodilator response, determined by changes in forced expiratory volume in 1 s (FEV1). In this study, we assessed bronchodilator response in patients with COPD using not only FEV1 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. 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. Treatments: twice daily budesonide/formoterol pressurized metered-dose inhaler (pMDI) 320/9 μg, budesonide/formoterol pMDI 160/9 μg, formoterol dry powder inhaler (DPI) 9 μg, placebo. Results: The percentage of patients with FEV1 improvement (≥12{\%} and ≥200 mL; 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 60 min: FEV1 (57-59{\%}). Similar results were seen for IC (50-61{\%}) and FVC (57-67{\%}) using the same improvement criteria. The time to ≥15{\%} FEV1 improvement on DOR was 5.0, 4.8, and 7.3 min for budesonide/formoterol 320/9, budesonide/formoterol 160/9, and formoterol, respectively. Time to ≥15{\%} FEV1 improvement was better maintained with budesonide/formoterol than formoterol at treatment end (6 and 12 months). 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 5 min) onset of bronchodilation that is maintained over time compared with formoterol alone.",
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N2 - Background: Chronic obstructive pulmonary disease (COPD) patients are thought to have limited bronchodilator response, determined by changes in forced expiratory volume in 1 s (FEV1). In this study, we assessed bronchodilator response in patients with COPD using not only FEV1 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. 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. Treatments: twice daily budesonide/formoterol pressurized metered-dose inhaler (pMDI) 320/9 μg, budesonide/formoterol pMDI 160/9 μg, formoterol dry powder inhaler (DPI) 9 μg, placebo. Results: The percentage of patients with FEV1 improvement (≥12% and ≥200 mL; 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 60 min: FEV1 (57-59%). Similar results were seen for IC (50-61%) and FVC (57-67%) using the same improvement criteria. The time to ≥15% FEV1 improvement on DOR was 5.0, 4.8, and 7.3 min for budesonide/formoterol 320/9, budesonide/formoterol 160/9, and formoterol, respectively. Time to ≥15% FEV1 improvement was better maintained with budesonide/formoterol than formoterol at treatment end (6 and 12 months). 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 5 min) onset of bronchodilation that is maintained over time compared with formoterol alone.

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