Back to Journals » International Journal of Chronic Obstructive Pulmonary Disease » Volume 15

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

Authors Kostikas K, Vassilakopoulos TI, Tzanakis N, Konstantinidis AK, Kosmas EN, Papiris S, Steiropoulos P, Manali ED, Michaelides SA, Daskos G

Received 18 November 2019

Accepted for publication 21 February 2020

Published 6 March 2020 Volume 2020:15 Pages 515—526


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Richard Russell

Konstantinos Kostikas,1 Theodoros I Vassilakopoulos,2,3 Nikos Tzanakis,4 Athanasios K Konstantinidis,1 Epameinondas N Kosmas,5 Spyros Papiris,6 Paschalis Steiropoulos,7 Effrosyni D Manali,6 Stylianos A Michaelides8,, Grigorios Daskos9

1Respiratory Medicine Department, University Hospital of Ioannina, Ioannina, Greece; 2Pulmonary and Critical Care Medicine, Medical School, National and Kapodistrian University of Athens, Athens, Greece; 3Third Department of Critical Care Medicine, Evgenideio Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece; 4Department of Respiratory Medicine, University Hospital of Heraklion, Medical School, University of Crete, Crete, Greece; 5Department of Pulmonary Medicine, Metropolitan Hospital, Athens, Greece; 6Second Pulmonary Medicine Department, General University Hospital “Attikon”, Medical School, National and Kapodistrian University of Athens, Athens, Greece; 7Pulmonology Clinic Medical School, Democritus University of Thrace/University General Hospital, Alexandroupolis, Greece; 8Department of Occupational Lung Disease and Tuberculosis, “Sismanogleio-Amalia Fleming” General Hospital, Athens, Greece; 9MENARINI HELLAS, Athens, Greece

Stylianos A Michaelides passed away on September 14, 2019

Correspondence: Konstantinos Kostikas
Respiratory Medicine Department, University of Ioannina School of Medicine, Leoforos Stavrou Niarchou, Ioannina 45500, Greece
Tel +30-2651007536

Purpose: 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.

Keywords: aclidinium, chronic obstructive pulmonary disease, COPD assessment test, daily activities, quality of life, symptoms

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]