Source: International Congress 2015 – New data on established treatments for asthma and COPD
Disease area: Airway diseases

Abstract

Introduction Measuring change in FEV₁ & COPD patient reported outcomes (PROs) such as SGRQ & TDI, rescue medication use & exacerbations are important to assess the overall effect of therapy in COPD patients (pts). However, the relationship between these changes has been rarely reported.We analysed 23 clinical trials in COPD patients treated with LABA [indacaterol (IND), salmeterol & formoterol], LAMA [glycopyrronium (GLY) & tiotropium] & LABA/LAMA dual bronchodilator (QVA149, fixed-dose combination of IND+GLY) to determine the relationship between change in trough FEV₁ & PROs.MethodsIndividual patient pooled data from randomised, parallel-group, placebo or active controlled studies (3 to18 months; 23,213 pts) were analysed.ResultsA significant correlation between improvement in trough FEV₁ & other endpoints was seen: exacerbations R_s = 0.05; rescue medication, SGRQ, TDI r = 0.11-0.16, all p<0.001. Patients with greater improvement in trough FEV₁ had on average better SGRQ & TDI scores, used less rescue medication & had fewer exacerbations. The SGRQ score differed by 7.1 between the decile of pts with the lowest & highest response in FEV₁ (figure1).ConclusionsAt a population level, statistically significant and clinically relevant relationships exist between improvements in trough FEV₁ and COPD PROs, but the correlations are too weak to be useful at an individual patient level.






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James F. Donohue (Chapel Hill, United States of America), James F. Donohue, Paul Jones, Christian Bartels, Jessica Marvel, Peter D’Andrea, Donald Banerji, Francesco Patalano, Robert Fogel. Relationship between change in trough FEV1 and COPD patient outcomes: Pooled analysis of 23 clinical trials in patients with COPD. Eur Respir J 2015; 46: Suppl. 59, 1013

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