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
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-blind
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
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
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