Extrafine Beclometasone Dipropionate/Formoterol NEXThaler on Device Usability, Adherence, Asthma Control and Quality of Life. A Panhellenic Prospective, Non-Interventional Observational Study in Patients with Asthma—The NEXT-Step Study
Background: The fixed combination of extrafine beclometasone dipropionate 100 μg/formoterol 6 μg (extrafine BDP/F) delivered by NEXThaler has proved to be effective in patients with moderate-to-severe asthma in terms of lung function, symptoms and asthma control. The aim of this study was to investi...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-01-01
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| Series: | Journal of Personalized Medicine |
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| Online Access: | https://www.mdpi.com/2075-4426/12/2/146 |
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| author | Petros Bakakos Panagiotis Chatziapostolou Panos Katerelos Petros Efstathopoulos Aliki Korkontzelou Paraskevi Katsaounou |
| author_facet | Petros Bakakos Panagiotis Chatziapostolou Panos Katerelos Petros Efstathopoulos Aliki Korkontzelou Paraskevi Katsaounou |
| author_sort | Petros Bakakos |
| collection | DOAJ |
| description | Background: The fixed combination of extrafine beclometasone dipropionate 100 μg/formoterol 6 μg (extrafine BDP/F) delivered by NEXThaler has proved to be effective in patients with moderate-to-severe asthma in terms of lung function, symptoms and asthma control. The aim of this study was to investigate the usability/satisfaction of NEXThaler and adherence to treatment in asthma patients not well controlled by low-dose inhaled corticosteroids (ICS). Methods: This was a 6-month prospective, multicenter, open-label, observational study in 661 patients with asthma not well controlled by low-dose ICS according to the physician’s clinical assessment, which have received regular treatment with extrafine BDP/F NEXThaler. Feeling of Satisfaction with Inhaler (FSI), treatment adherence with self-reported Morisky scale, asthma control, lung function and QoL were recorded at baseline, 3 and 6 months after treatment with extrafine BDP/F. Results: The percentage of patients at least “fairly” satisfied with NEXThaler usability (FSI-10 score 40 to 50) was 96.3%. The mean FSI-10 total score was 46.8 ± 4.4 on Visit 2 and increased to 48.1 ± 3.3 on Visit 3 (<i>p</i> < 0.001). Approximately 67% of the patients reported “high adherence” on Visit 2, and 70% of them reported “high adherence” on Visit 3. The percentage of patients with ACQ-6-uncontrolled asthma decreased from 79.1% on Visit 1 to 22.3% on Visit 2 and further decreased to 6.7% on Visit 3. Significant improvements were also observed in the total AQLQ score, predicted FEV1% and reduction in rescue medication use. Conclusions: The NEXThaler device, delivering a combination of BDP/F, achieves satisfaction and high adherence in patients with asthma not well controlled with low-dose ICS. Asthma control, QoL, lung function and rescue medication use were improved in a Greek real-world setting. |
| first_indexed | 2024-03-09T21:37:55Z |
| format | Article |
| id | doaj.art-11d16ce7cd144748b9b09b53fc085e30 |
| institution | Directory Open Access Journal |
| issn | 2075-4426 |
| language | English |
| last_indexed | 2024-03-09T21:37:55Z |
| publishDate | 2022-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Personalized Medicine |
| spelling | doaj.art-11d16ce7cd144748b9b09b53fc085e302023-11-23T20:38:57ZengMDPI AGJournal of Personalized Medicine2075-44262022-01-0112214610.3390/jpm12020146Extrafine Beclometasone Dipropionate/Formoterol NEXThaler on Device Usability, Adherence, Asthma Control and Quality of Life. A Panhellenic Prospective, Non-Interventional Observational Study in Patients with Asthma—The NEXT-Step StudyPetros Bakakos0Panagiotis Chatziapostolou1Panos Katerelos2Petros Efstathopoulos3Aliki Korkontzelou4Paraskevi Katsaounou51st University Department of Respiratory Medicine, Medical School, National and Kapodistrian University of Athens, “Sotiria” Chest Diseases Hospital, 11527 Athens, GreecePulmonary Clinic, Euromedica General Clinic of Thessaloniki, 54645 Thessaloniki, GreeceBioStatistics PC, 11474 Athens, GreeceChiesi Hellas S.A., 17455 Alimos, GreeceChiesi Hellas S.A., 17455 Alimos, GreecePulmonary and Respiratory Failure Department, First ICU, Evangelismos Hospital, 10676 Athens, GreeceBackground: The fixed combination of extrafine beclometasone dipropionate 100 μg/formoterol 6 μg (extrafine BDP/F) delivered by NEXThaler has proved to be effective in patients with moderate-to-severe asthma in terms of lung function, symptoms and asthma control. The aim of this study was to investigate the usability/satisfaction of NEXThaler and adherence to treatment in asthma patients not well controlled by low-dose inhaled corticosteroids (ICS). Methods: This was a 6-month prospective, multicenter, open-label, observational study in 661 patients with asthma not well controlled by low-dose ICS according to the physician’s clinical assessment, which have received regular treatment with extrafine BDP/F NEXThaler. Feeling of Satisfaction with Inhaler (FSI), treatment adherence with self-reported Morisky scale, asthma control, lung function and QoL were recorded at baseline, 3 and 6 months after treatment with extrafine BDP/F. Results: The percentage of patients at least “fairly” satisfied with NEXThaler usability (FSI-10 score 40 to 50) was 96.3%. The mean FSI-10 total score was 46.8 ± 4.4 on Visit 2 and increased to 48.1 ± 3.3 on Visit 3 (<i>p</i> < 0.001). Approximately 67% of the patients reported “high adherence” on Visit 2, and 70% of them reported “high adherence” on Visit 3. The percentage of patients with ACQ-6-uncontrolled asthma decreased from 79.1% on Visit 1 to 22.3% on Visit 2 and further decreased to 6.7% on Visit 3. Significant improvements were also observed in the total AQLQ score, predicted FEV1% and reduction in rescue medication use. Conclusions: The NEXThaler device, delivering a combination of BDP/F, achieves satisfaction and high adherence in patients with asthma not well controlled with low-dose ICS. Asthma control, QoL, lung function and rescue medication use were improved in a Greek real-world setting.https://www.mdpi.com/2075-4426/12/2/146asthmaNEXThalerusabilitysatisfactionadherencequality of life |
| spellingShingle | Petros Bakakos Panagiotis Chatziapostolou Panos Katerelos Petros Efstathopoulos Aliki Korkontzelou Paraskevi Katsaounou Extrafine Beclometasone Dipropionate/Formoterol NEXThaler on Device Usability, Adherence, Asthma Control and Quality of Life. A Panhellenic Prospective, Non-Interventional Observational Study in Patients with Asthma—The NEXT-Step Study Journal of Personalized Medicine asthma NEXThaler usability satisfaction adherence quality of life |
| title | Extrafine Beclometasone Dipropionate/Formoterol NEXThaler on Device Usability, Adherence, Asthma Control and Quality of Life. A Panhellenic Prospective, Non-Interventional Observational Study in Patients with Asthma—The NEXT-Step Study |
| title_full | Extrafine Beclometasone Dipropionate/Formoterol NEXThaler on Device Usability, Adherence, Asthma Control and Quality of Life. A Panhellenic Prospective, Non-Interventional Observational Study in Patients with Asthma—The NEXT-Step Study |
| title_fullStr | Extrafine Beclometasone Dipropionate/Formoterol NEXThaler on Device Usability, Adherence, Asthma Control and Quality of Life. A Panhellenic Prospective, Non-Interventional Observational Study in Patients with Asthma—The NEXT-Step Study |
| title_full_unstemmed | Extrafine Beclometasone Dipropionate/Formoterol NEXThaler on Device Usability, Adherence, Asthma Control and Quality of Life. A Panhellenic Prospective, Non-Interventional Observational Study in Patients with Asthma—The NEXT-Step Study |
| title_short | Extrafine Beclometasone Dipropionate/Formoterol NEXThaler on Device Usability, Adherence, Asthma Control and Quality of Life. A Panhellenic Prospective, Non-Interventional Observational Study in Patients with Asthma—The NEXT-Step Study |
| title_sort | extrafine beclometasone dipropionate formoterol nexthaler on device usability adherence asthma control and quality of life a panhellenic prospective non interventional observational study in patients with asthma the next step study |
| topic | asthma NEXThaler usability satisfaction adherence quality of life |
| url | https://www.mdpi.com/2075-4426/12/2/146 |
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