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

Abstract

Purpose

The rationale of this study was to investigate the prevalence of daily and night symptoms and quality of sleep in Greek COPD patients as a means to evaluate their response to treatment with the fixed dose combination of aclidinium/formoterol (administered through the Genuair^® device).

Patients and Methods

This study was a multicenter, nationwide, non-interventional, observational study in 2105 patients suffering from COPD, who have recently started treatment with aclidinium/formoterol. Patients were attending to two visits, one baseline and a final visit, 3 months later. Different variables have been collected on either the baseline or the final visit or both: demographics, vital sign measurements, COPD-related medical history parameters, comorbidities, COPD assessment test (CAT), COPD severity based on spirometry measurements, COPD stage based on the ABCD assessment approach proposed by the 2019 Global Initiative for Chronic Obstructive Lung Disease (GOLD), COPD treatment report, and severity of early-morning, daytime and night-time COPD-related symptoms. Reasons for prescribing aclidinium/formoterol, satisfaction of patients to the treatment, as well as their compliance have also been recorded.

Results

After 3 months on aclidinium/formoterol, 50.1% of the patients experienced an improvement in their early-morning symptoms. Furthermore, 49.9% of them experienced an improvement in their daily symptoms, 44.9% improved their night-time symptoms and 43.2% reduced the frequency of overnight sleep disruptions due to COPD symptoms. These favorable outcomes apply mainly to GOLD Groups B–D. Treatment with aclidinium/formoterol improved on average the pre-bronchodilation FEV1% pred by 3.18%, the post-bronchodilation FEV1% pred by 2.78% and reduced CAT score by 5.22 points. Satisfaction with using aclidinium/formoterol across patients was high, as well as compliance to therapy.

Conclusion

Aclidinium/formoterol provided significant benefits on the quality of life of COPD patients by reducing the morning, daytime and the night-time symptoms and symptom burden in GOLD Groups B–D, and activity impairment under real-life conditions in all GOLD ABCD groups.

Keywords:

• COPD
• dual-bronchodilation therapy
• aclidinium/formoterol
• daytime and night-time symptoms
• GOLD ABCD classification

Data Sharing Statement

All data of this study are contained in this manuscript and Supplementary Materials.

Ethics Approval and Informed Consent

Please refer to the Materials and Methods section (Bioethical Considerations subsection) for full details.

Acknowledgments

Moreover, the authors would like to express their gratitude to Diamantis Chloros (Pulmonary Department, Aristotle University of Thessaloniki, “G. Papanikolaou” Hospital, Exohi, Greece), Georgatou Niki (Lung Specialist, Director, Iatriko Athinon, Areos 41, Paleo Faliro), Pechlivanidou Rouzana (Pulmonary Department, General Hospital of Serres, Serres, Greece), Emmanouil Ferdoutsis (Department of Pneumonology, Medical School University of Crete, Crete, Greece), Antonia Digalaki (5th Respiratory Medicine Department, General Hospital for Chest Diseases “SOTIRIA”, Athens, Greece), who significantly assisted in data collection, and Ioannis Violaris and Alexandros Tzallas (Department of Informatics & Telecommunications, School of Informatics & Telecommunications, University of Ioannina), who supported data analysis.

Author Contributions

K.KO, K.D., K.G. and N.T. conceived, designed and coordinated the study, and assisted in manuscript preparation. M.G., D.P., G.T. and P.C. coordinated data collection and processing, performed quality controls during the study execution, and assisted in manuscript preparation. A.A., G.M., E.E. and P.S. performed data collection, and assisted in data analysis and manuscript preparation. I.K., A.G. and K.KA. performed the data analysis, interpretation and wrote the main manuscript text. All authors took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The Respiratory Medicine Department (Konstantinos Kostikas) and the Department of Informatics and Telecommunications (Konstantinos Kalafatakis and Ioannis Violaris) of the University of Ioannina have received funding from Menarini Hellas S.A. Dr Konstantinos Kostikas reports grants, personal fees from AstraZeneca, grants, personal fees from Boehringer Ingelheim, personal fees from CSL Behring, grants, personal fees from Chiesi, grants, personal fees from ELPEN, personal fees from GILEAD, grants, personal fees from GSK, grants, personal fees from Menarini, grants, personal fees from Novartis, grants, personal fees from Sanofi, grants from NuvoAir, outside the submitted work. Dr Panagiota Styliara reports they are an employee of Menarini Hellas that conducted the study, during the conduct of the study. Dr Athena Gogali reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, ELPEN, GSK, Novartis, outside the submitted work. Dr Konstantinos Kalafatakis reports grants from MENARINI HELLAS S.A., during the conduct of the study. Professor Nikolaos Tzanakis reports grants, personal fees from GSK, AstraZeneca, Novartis, Boehringer Ingelheim, ELPEN, MENARINI and NYCOMED; personal fees from PHARMATEN, INOVIS and GILEAD outside the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Additional information

Funding

The DANICO study has been sponsored by Menarini Hellas S.A.