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

Konstantinos Kostikas,1 Katerina Dimakou,2 Konstantinos Gourgoulianis,3 Mina Gaga,4 Dimosthenis Papapetrou,5 Georgios Tsoukalas,6 Panagiotis Chatziapostolou,7 Antonios Antoniadis,8 Georgios Meletis,9 Efstathia Evangelopoulou,10 Panagiota Styliara,11 Ilektra Karypidou,12 Athena Gogali,1 Konstantinos Kalafatakis,13,14 Nikolaos Tzanakis15 1Respiratory Medicine Department, University Hospital of Ioannina, Ioannina, Greece; 2 5th Respiratory Medicine Department, General Hospital for Chest Diseases of Athens “SOTIRIA”, Athens, Greece; 3Department of Respiratory Medicine, University of Thessaly, Larissa, Greece; 4 7th Respiratory Medicine Department, General Hospital for Chest Diseases of Athens “SOTIRIA”, Athens, Greece; 5Iatriko Athinon, Paleo Faliro, Attiki, Greece; 6 4th Respiratory Medicine Department, General Hospital for Chest Diseases of Athens “SOTIRIA”, Athens, Greece; 7Department of Pulmonary Medicine, Euromedica General Clinic, Thessaloniki, Greece; 8Department of Pulmonary Medicine, General Hospital of Serres, Serres, Greece; 9Department of Pulmonary Medicine, General Hospital of Heraklion “VENIZELEIO”, Heraklion, Greece; 10Respiratory Medicine Department, General Hospital of Nikaia “ST. PANTELEIMON”, Piraeus, Greece; 11Menarini Hellas, Athens, Greece; 12Department of Pulmonary Medicine, General Hospital of Thessaloniki “GEORGIOS PAPANIKOLAOU”, Thessaloniki, Greece; 13Department of Informatics & Telecommunications, University of Ioannina, Arta, Greece; 14Barts and the London School of Medicine & Dentistry, Queen Mary University of London (Malta Campus), Victoria, Gozo, Malta; 15Department of Respiratory Medicine, University General Hospital of Heraklion, Heraklion, GreeceCorrespondence: Konstantinos Kostikas, Respiratory Medicine & Head of Respiratory Medicine Department, University Hospital of Ioannina, Ioannina, Greece, Tel [phone], Email [email protected]; [email protected]: 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

Keywords

• copd
• dual-bronchodilation therapy
• aclidinium/formoterol
• daytime and night-time symptoms
• gold abcd classification