RT Journal Article
SR Electronic
T1 Effect of roflumilast on quality of life in frequent and infrequent exacerbators
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P4150
VO 42
IS Suppl 57
A1 Peter Kardos
A1 Ingo Makros
A1 Claus Vogelmeier
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/P4150.abstract
AB BackgroundCOPD exacerbations deteriorate quality of life (QoL) in COPD patients. This single-arm, non-interventional study investigated the effects of add-on roflumilast 500µg o.d. on QoL, assessed using the COPD Clinical Questionnaire (CCQ) and the COPD Assessment Test™ (CAT). Primary results were reported elsewhere. Here we report results on subgroups stratified by exacerbation frequency.MethodsPatients with severe COPD (65% male; mean age: 65.5±9.9 years; mean BMI 27.3±5.7 kg/m2) were treated with roflumilast under real-life conditions for 6 months (intention-to-treat, ITT). Frequent exacerbators (FE) (n=1,841) were defined as patients with ≥2 moderate/severe exacerbations, and infrequent exacerbators (IFE) (n=1,736) as having <2 in the 12 months prior to study start (V1). CCQ and CAT scores were measured at V1, 3 months (V2) and 6 months (V3).ResultsThere was significant improvement from V1 in total CCQ scores (±SD) at V3 in both FE (−1.0±1.1; n=999) and IFE (−0.7±1.0; n=848) (p<0.001). Improvements from V1 in each CCQ domain at V2 and V3 were also reported in both subgroups (p<0.001). Changes were larger in FE versus IFE at V3 (between-group comparison: p<0.001). These results were confirmed in the per-protocol analysis.Mean changes in total CAT scores between V1 and V3 were –6.6±7.3 (N=962) in FE and –4.9±7.3 (N=809) in IFE (both p<0.001). Changes were also larger in FE compared with IFE (between-group comparison: p<0.001).ConclusionsRoflumilast significantly improved health status, as measured by both CCQ and CAT in frequent exacerbators and infrequent exacerbators, respectively. Improvements were clinically meaningful and more pronounced in frequent exacerbators.