Assessment of patient-reported outcomes by questionnaires in patients with moderate and severe chronic obstructive pulmonary disease treated with glycopyrronium in the real life setting in Hungary (AMULET)

Abstract

Introduction: Chronic obstructive pulmonary disease (COPD) is a multifactorial disorder, therefore, airflow limitation alone does not reflect the full burden of COPD. In Hungary, no national data are available yet about the results obtained with the different COPD questionnaires in daily patient care, and about difficulties of questionnaires for patients. Aim and method: The aim of the study was to evaluate patient-reported outcomes with guideline-suggested questionnaires (CCQ, CAT, mMRC, EQ-5D-5L) in patients treated with glycopyrronium-bromide (therapy naïve, add-on combination or switch from another therapy) in the real life setting during 16 weeks treatment. This study was open-label, multi-centre, non-interventional, observational. Results: 527 patients were enrolled in the study (mean age: 63.8 ± 9.64 years, mean FEV1: 59.8 ± 15.12%). In all of the groups, the CCQ mean scores, all of the CCQ subscores, CAT and mMRC scores significantly decreased from visit 1 to visit 3. The EQ-5D-5L index and VAS scores increased significantly between visits. According to investigators’ opinion, the CAT test reflects the patient’s condition better (84.7%) than CCQ or mMRC; also, from the patient’s point of view, CAT was simpler and easier to understand (83.2%). There was a positive, statistically significant correlation between CCQ and CAT (rs = 0.711, p<0.001), between CCQ and mMRC (rs = 0.524, p<0.001) and between CAT and mMRC scores at visit 3 (rs = 0.475, p<0.001). Conclusion: Our results suggest that the CAT test may be simpler and easier to understand for patients. Also, according to investigators’ opinion, CAT reflects the patient’s condition better, so CAT appears to be the most promising tool in COPD evaluation.