Research
Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis
1 Division of Clinical Science, St George's, University of London, London, UK
2 Division of Pulmonary & Critical Care Medicine, University of North Carolina, School of Medicine, Chapel Hill, NC, USA
3 Novartis Pharmaceuticals Corporation, East Hanover, USA
4 Novartis Pharma AG, Basel, Switzerland
5 Novartis Horsham Research Centre, Horsham, West Sussex, UK
Respiratory Research 2011, 12:161 doi:10.1186/1465-9921-12-161
Published: 29 December 2011Abstract
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
ClinicalTrials.gov NCT00393458, NCT00463567, and NCT00624286
