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Peter Kardos,1 Ingo Mokros,2 Rüdiger Sauer,3,4 Claus F Vogelmeier5,6 1Group Practice and Centre for Allergy, Respiratory, and Sleep Medicine, at Maingau Red Cross Hospital, Frankfurt am Main, Germany; 2AstraZeneca GmbH, Unternehmensbereich Medizin, Wedel, Germany; 3Group Practice with Respiratory, Allergy and Sleep Unite, Lung Center, Ulm, Germany; 4Health Center Clinic Blaubeuren, Blaubeuren, Germany; 5Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, Marburg, Germany; 6German Center for Lung Research (DZL), Giessen, Germany Purpose: DINO and DACOTA were prospective, noninterventional studies assessing the health status and quality of life of patients with COPD newly treated with roflumilast 500 µg once-daily add-on therapy.Patients and methods: Patients were evaluated over 6 months. Clinical COPD questionnaire (CCQ) and COPD assessment test (CAT) scores were recorded at baseline and after 3 and 6 months. In DACOTA, post-bronchodilator FEV1 was recorded at each time point.Results: Of 5,462 and 3,645 patients recruited into DINO and DACOTA, respectively, 3,274 patients in DINO and 916 patients in DACOTA completed the 6-month visit. Almost all patients had severe or very severe airway obstruction; mean baseline CCQ total score was 3.9 in DINO and 3.7 in DACOTA. Overall, 33.8% of patients in DACOTA and 30.6% in DINO discontinued treatment prematurely. Significant and clinically relevant improvements in CCQ total scores were observed in both studies (mean change from baseline of 1.36 in DINO and 0.91 in DACOTA at Month 6 [all P |
