<p>A Real-World Observational Study Examining the Impact of Aclidinium Bromide Therapy on the Quality of Life, Symptoms, and Activity Impairment of Patients with Chronic Obstructive Pulmonary Disease: The Greek ON-AIR Study</p>

Abstract

This multicenter, prospective, observational study aimed to supplement real-world evidence on the effects of aclidinium bromide on the quality of life (QoL), symptoms, and activity impairment of patients with COPD. Patients and Methods: Eligible patients were ≥40 years of age, newly initiated on aclidinium bromide as monotherapy or add-on therapy according to the product's approved label. Patient-reported COPD assessment test (CAT), the severity of symptoms and their impact on daily activities, and the features of the Genuair ® inhaler device were assessed at enrollment and at 12 weeks post-treatment onset. Results: Between 13 March 2015 and 29 January 2016, 285 eligible consenting patients (76.3% males; median age: 69.0 years; 26.0% newly diagnosed with COPD) were enrolled by 15 hospital-based respiratory medicine specialists in Greece. Aclidinium bromide was initiated as add-on therapy to other inhaled maintenance medications in 73.1% of evaluable patients. The median (interquartile range [IQR]) baseline CAT score decreased from 14.0 (9.0-20.0) to 10.0 (6.0-15.0) points (p<0.001) after 12 weeks of treatment, with 76.5% of the patients achieving a ≥2-point decrease. The severity of night-time and early-morning symptoms, assessed using a 5-point Likert-type scale, decreased from a median (IQR) of 1.0 (0.0-2.0) to 0.0 (0.0-1.0), and from 2.0 (1.0-2.0) to 1.0 (1.0-2.0), respectively (p<0.001 for both). In patients with paired data, the prevalence of at least moderate night-time symptoms, early-morning symptoms, and daily activity impairment decreased from 28.2% to 19.1%, from 63.6% to 34.2%, and from 59.5% to 38.7%, respectively (p<0.001 for all). Inhaler device features were assessed as "very good"/"good" by more than 90% of the patients. The adverse drug reaction rate was 1.4%. Conclusion: The study provides real-world evidence on the beneficial effects of aclidinium bromide on the patients' QoL, symptom severity, and daily activity impairment, which are complemented by a favorable safety profile and high patient satisfaction with the inhaler device.

A Real-World Study on the Day and Night-Time Symptoms Among Greek COPD Patients Who Recently Initiated Treatment with Dual Bronchodilation: The DANICO Study

“…The features of our population sample show similarities to other large epidemiological studies conducted in Greece and abroad. [17][18][19][20][21] In almost half of the cases (48.6%), the treating physician decided to prescribe aclidinium/formoterol due to the fact that patients were still symptomatic while on previous treatment (including lack of efficacy of ICS-containing approaches). Other common reasons included disease progression and thus choice of aclidinium/formoterol as an add-on therapy, occurrence of exacerbations while on previous treatment, or inappropriate use of ICS.…”

Targeting exertional breathlessness to improve physical activity: the role of primary care

“…Aclidinium therapy improved quality of life, as demonstrated by reductions in mean COPD Assessment Test™ score, and reduced the severity of night-time and early-morning symptoms 67 . At least moderate impairment in performance of daily activities due to COPD symptoms was reported by 59.5% of patients at enrolment, improving to 38.7% after 12 weeks of aclidinium treatment 67 . Tiotropium improves physical functioning, with 61.5% of patients achieving an improvement of ≥10 points in the Physical Function subdomain after 6 weeks of treatment 68 .…”

“…In addition, several real-world studies suggest that bronchodilators have a beneficial effect on physical activity. In terms of monotherapy, the ON-AIR real-world evidence study evaluated the effects of the LAMA aclidinium bromide on quality of life, symptom severity and daily activity impairment in patients with COPD 67 . Aclidinium therapy improved quality of life, as demonstrated by reductions in mean COPD Assessment Test™ score, and reduced the severity of night-time and early-morning symptoms 67 .…”

“…In terms of monotherapy, the ON-AIR real-world evidence study evaluated the effects of the LAMA aclidinium bromide on quality of life, symptom severity and daily activity impairment in patients with COPD 67 . Aclidinium therapy improved quality of life, as demonstrated by reductions in mean COPD Assessment Test™ score, and reduced the severity of night-time and early-morning symptoms 67 . At least moderate impairment in performance of daily activities due to COPD symptoms was reported by 59.5% of patients at enrolment, improving to 38.7% after 12 weeks of aclidinium treatment 67 .…”