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

Abstract

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.

Journal

Journal ID (nlm-ta): Int J Chron Obstruct Pulmon Dis

Journal ID (iso-abbrev): Int J Chron Obstruct Pulmon Dis

Journal ID (publisher-id): COPD

Journal ID (pmc): copd

Title: International Journal of Chronic Obstructive Pulmonary Disease

Publisher: Dove

ISSN (Print): 1176-9106

ISSN (Electronic): 1178-2005

Publication date (Electronic): 06 March 2020

Publication date Collection: 2020

Volume: 15

Pages: 515-526

Affiliations

[1 ]Respiratory Medicine Department, University Hospital of Ioannina , Ioannina, Greece

[2 ]Pulmonary and Critical Care Medicine, Medical School, National and Kapodistrian University of Athens , Athens, Greece

[3 ]Third Department of Critical Care Medicine, Evgenideio Hospital, Medical School, National and Kapodistrian University of Athens , Athens, Greece

[4 ]Department of Respiratory Medicine, University Hospital of Heraklion, Medical School, University of Crete , Crete, Greece

[5 ]Department of Pulmonary Medicine, Metropolitan Hospital , Athens, Greece

[6 ]Second Pulmonary Medicine Department, General University Hospital “Attikon”, Medical School, National and Kapodistrian University of Athens , Athens, Greece

[7 ]Pulmonology Clinic Medical School, Democritus University of Thrace/University General Hospital , Alexandroupolis, Greece

[8 ]Department of Occupational Lung Disease and Tuberculosis, “Sismanogleio-Amalia Fleming” General Hospital , Athens, Greece

[9 ]MENARINI HELLAS , Athens, Greece

Author notes

Correspondence: Konstantinos Kostikas Respiratory Medicine Department, University of Ioannina School of Medicine , Leoforos Stavrou Niarchou, Ioannina45500, GreeceTel [phone] Email [e-mail]

[†]

Stylianos A Michaelides passed away on September 14, 2019

Article

Publisher ID: 239044

DOI: 10.2147/COPD.S239044

PMC ID: 7064283

Copyright statement: © 2020 Kostikas et al.

License:

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Page count

Figures: 4, Tables: 3, References: 33, Pages: 12

Funding

The study was sponsored by Menarini Hellas. The study Sponsor was involved in the study concept and design and in the interpretation of the data included in this publication, but not in the data collection and analysis. Menarini Hellas also funded the medical writing support for this publication.

Categories

Subject: Original Research