Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis Public Deposited

Downloadable Content

Download PDF
  • Pinault, Gregory
    • Other Affiliation: Novartis Pharma AG, Basel, Switzerland
  • Jones, Paul W
    • Other Affiliation: Division of Clinical Science, St George’s, University of London, London, UK
  • Donohue, James F
    • Affiliation: School of Medicine, Department of Medicine, Division of Pulmonary Diseases and Critical Care Medicine
  • Pascoe, Steve
    • Other Affiliation: Novartis Pharma AG, Basel, Switzerland
  • Lassen, Cheryl
    • Other Affiliation: Novartis Horsham Research Centre, Horsham, West Sussex, UK
  • Nedelman, Jerry
    • Other Affiliation: Novartis Pharmaceuticals Corporation, East Hanover, USA
  • Abstract Background Relationships between improvements in lung function and other clinical outcomes in chronic obstructive pulmonary disease (COPD) are not documented extensively. We examined whether changes in trough forced expiratory volume in 1 second (FEV1) are correlated with changes in patient-reported outcomes. Methods Pooled data from three indacaterol studies (n = 3313) were analysed. Means and responder rates for outcomes including change from baseline in Transition Dyspnoea Index (TDI), St. George's Respiratory Questionnaire (SGRQ) scores (at 12, 26 and 52 weeks), and COPD exacerbation frequency (rate/year) were tabulated across categories of ΔFEV1. Also, generalised linear modelling was performed adjusting for covariates such as baseline severity and inhaled corticosteroid use. Results With increasing positive ΔFEV1, TDI and ΔSGRQ improved at all timepoints, exacerbation rate over the study duration declined (P < 0.001). Individual-level correlations were 0.03-0.18, but cohort-level correlations were 0.79-0.95. At 26 weeks, a 100 ml increase in FEV1 was associated with improved TDI (0.46 units), ΔSGRQ (1.3-1.9 points) and exacerbation rate (12% decrease). Overall, adjustments for baseline covariates had little impact on the relationship between ΔFEV1 and outcomes. Conclusions These results suggest that larger improvements in FEV1 are likely to be associated with larger patient-reported benefits across a range of clinical outcomes. Trial Registration NCT00393458 , NCT00463567 , and NCT00624286
Date of publication
  • doi:10.1186/1465-9921-12-161
  • 22206353
Resource type
  • Article
Rights statement
  • In Copyright
Rights holder
  • Paul W Jones et al.; licensee BioMed Central Ltd.
Journal title
  • Respiratory Research
Journal volume
  • 12
Journal issue
  • 1
Page start
  • 161
  • English
Is the article or chapter peer-reviewed?
  • Yes
  • 1465-9921
Bibliographic citation
  • Respiratory Research. 2011 Dec 29;12(1):161
  • Open Access
  • BioMed Central Ltd

This work has no parents.