Symptom severity and quality of life in COPD patients treated with aclidinium bromide: results of a non-interventional study

Introduction: For many COPD patients, symptoms such as dyspnea and cough are most burdensome in the morning, followed by the night. This multi-center, prospective, non-interventional study investigated quality of life (QoL) and severity of nighttime and morning symptoms in patients treated with aclidinium bromide, a novel inhaled muscarinic antagonist, in daily practice.

Methods: COPD patients ≥40 years of age and newly initiated on treatment with aclidinium bromide (Eklira® Genuair®; recommended dose: 400 µg twice daily) could be included. The intensity of their nighttime and morning symptoms and the impact of COPD on morning activities were assessed by the patients on 5-point scales (absent, mild, moderate, severe, very severe) at study start (baseline) and after approximately 12 weeks of treatment. Health-related QoL was measured by means of the COPD Assessment Test (CAT) at both visits. Features of the inhaler were assessed by patients and physicians on 4-point scales (very good, good, moderate, poor) at the end of the observation.

Results: A total of 4371 patients (median age: 64 years; median time since first diagnosis of COPD: 6 years) were included and treatment was observed for a mean period of 13 ± 4 weeks. The proportion of patients with COPD symptoms of at least moderate intensity decreased from 62.4% to 31.6% (nighttime) and from 72.2% to 35.5% (morning). Similarly, the proportion of patients with at least moderate limitation of morning activities decreased from 69.5% to 36.9%. The mean CAT total score decreased clinically relevantly from 22.2 ± 7.4 to 15.9 ± 7.3 (N= 4159; both visits). Most physicians (> 94%) and patients (> 91%) assessed the features of the inhaler as being very good or good.

Conclusions: The results may indicate beneficial treatment effects of aclidinium bromide on symptom severity, limitation of morning activities, and QoL (as measured by the CAT) in real-life COPD. Patient and physician assessments suggest a high level of inhaler satisfaction.