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

Respiratory Research

Cheryl Lassen³  Gregory Pinault⁴  Steve Pascoe⁴  Jerry Nedelman⁵  James F Donohue¹  Paul W Jones² 

[1] Division of Pulmonary & Critical Care Medicine, University of North Carolina, School of Medicine, Chapel Hill, NC, USA;Division of Clinical Science, St George's, University of London, London, UK;Novartis Horsham Research Centre, Horsham, West Sussex, UK;Novartis Pharma AG, Basel, Switzerland;Novartis Pharmaceuticals Corporation, East Hanover, USA

关键词: dyspnoea;    health status;    FEV₁;    spirometry;    COPD;   

Others  :  796761
DOI  :  10.1186/1465-9921-12-161

 received in 2011-10-06, accepted in 2011-12-29,  发布年份 2011

【 摘 要 】

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

【 授权许可】

   
2011 Jones et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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