Symptom assessment by means of the COPD-Assessment Test (CAT) in patients treated with Roflumilast: the DINO study (Daxas in COPD therapy)

Background Improving quality of life (QoL) and reducing the COPD-related symptoms are an important part of COPD management. This single-arm, non-interventional study investigated the effects of add-on roflumilast on patients' health status and symptoms in routine clinical practice by using the COPD Assessment Test TM (CAT) and a COPD symptom scale. Methods According to labelling, a total of 5,375 COPD patients (intention-to-treat, ITT) were treated with roflumilast 500 µg for up to 6 months. This study was performed at 2195 sites in Germany. CAT scores were measured at study start (V1), after 3 (V2) and 6 months (V3). COPD-related symptoms like cough, sputum production and cough up of sputum were evaluated on a 4-point scale (no/mild/moderate/severe symptoms). Results During the study, the mean CAT total score decreased from 26.8 ± 7.0 (n = 4,503) at V1 to 21.3 ± 7.1 (n = 3,071) at V2 and 18.1 ± 7.6 (n = 3,048) at V3 (ITT). The mean changes in the CAT score from V1 to V2 (-5.5 ± 5.1) and from V1 to V3 (-8.7 ± 6.9) were both statistically significant (p < 0.001) and clinically relevant with a reduction well above the MCID of 2 points (minimal clinical important difference). The improvement in the CAT total score (above MCID) was seen in at least 67.6% of the patients at V2 which further increased to 74.1% at V3. At V1, many patients suffered from severe COPD-related symptoms: cough, sputum production and coughing up sputum. After 6 months of roflumilast therapy, in about 60% of the patients (ITT) the severity of these symptoms decreased. Conclusion In real-life clinical practice a 6 month add-on roflumilast treatment resulted in a significant and clinically relevant improvement in COPD-related health status and COPD-related symptoms.