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

Creators: Jones, Paul W, Donohue, James F, Nedelman, Jerry, Pascoe, Steve, Pinault, Gregory, Lassen, Cheryl

File Type: pdf | Filesize: 605.8 KB | Date Added: 2012-08-23 | Date Created: 2011-12-29

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 &#916;FEV1. Also, generalised linear modelling was performed adjusting for covariates such as baseline severity and inhaled corticosteroid use. Results With increasing positive &#916;FEV1, TDI and &#916;SGRQ improved at all timepoints, exacerbation rate over the study duration declined (P &lt; 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), &#916;SGRQ (1.3-1.9 points) and exacerbation rate (12% decrease). Overall, adjustments for baseline covariates had little impact on the relationship between &#916;FEV1 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