Assessment of Symptoms Control, Pulmonary Function and Related Quality of Life in Asthmatic Patients Treated with Extrafine Beclomethasone Dipropionate/Formoterol Fumarate 100/6 μg pMDI: Results of a Multicenter Observational Study in Romania (ALFRESCO Study)
Ruxandra Ulmeanu,1 Sebastian Bloju,2 Oana Vittos3 1Postgraduate Training School of the Romanian Society of Pulmonology; Bronchoscopy Department - Institute of Pulmonology “Marius Nasta”, Bucharest, Romania; 2Medical Department, Chiesi Romania, Bucharest, Romania; 3Clinical Research Department, Medon...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2022-07-01
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| Series: | Journal of Asthma and Allergy |
| Subjects: | |
| Online Access: | https://www.dovepress.com/assessment-of-symptoms-control-pulmonary-function-and-related-quality--peer-reviewed-fulltext-article-JAA |
| _version_ | 1818518408769044480 |
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| author | Ulmeanu R Bloju S Vittos O |
| author_facet | Ulmeanu R Bloju S Vittos O |
| author_sort | Ulmeanu R |
| collection | DOAJ |
| description | Ruxandra Ulmeanu,1 Sebastian Bloju,2 Oana Vittos3 1Postgraduate Training School of the Romanian Society of Pulmonology; Bronchoscopy Department - Institute of Pulmonology “Marius Nasta”, Bucharest, Romania; 2Medical Department, Chiesi Romania, Bucharest, Romania; 3Clinical Research Department, Medone Research, Bucharest, RomaniaCorrespondence: Oana Vittos, Clinical Research Department, Medone Research, 18, Alexandr Sergheevici Puskin Street, District 1, Bucharest, 011996, Romania, Tel +40 21 311 11 05, Fax +40 21 311 11 06, Email toanaoana@medone.roIntroduction: Asthma treatment guidelines advocate the use of long-acting beta2-agonists (LABA) in addition to inhaled corticosteroids (ICS) in patients whose asthma is uncontrolled by ICS alone. This is the first study done in Romania, which collected the real-world data on the effects of Foster® (extrafine beclomethasone dipropionate/formoterol fumarate BDP/FF in a pressurized metered-dose inhaler pMDI 100/6 μg formulation) in adult asthmatic population.Objective: We aimed to assess the asthma symptoms control, pulmonary function and quality of life parameters in a heterogeneous Romanian asthmatic adult outpatient population, treated with extrafine BDP/FF 100/6 μg pMDI.Methods: This was a prospective, multicenter, observational study involving 30 pulmonologists randomly selected from the Romanian healthcare system, which did not declare any competing interests. Recruitment period was Oct 2018 - Feb 2019, while the patients’ observational period was 24 weeks. The study included poorly controlled and uncontrolled adult asthma outpatients treated with non-extrafine formulations medication, for which the treatment indication, according to Global Initiative for Asthma (GINA) 2018, was the use of an ICS-LABA combination. The study collected demographic data, smoking habits, comorbidities, data regarding asthma diagnosis, the evolution of asthma symptoms, spirometry, Asthma Control Questionnaire (ACQ-7) scoring test, current and concomitant treatment.Results: Of 302 included patients, 290 completed the study. Pulmonary function parameters assessed during the trial (forced expiratory volume in one second - FEV1 and forced vital capacity - FVC) showed a significant improvement versus baseline (p< 0.001). ACQ-7 score decreased significantly from 3.09± 0.83 (visit 1) to 1.56± 0.89 (visit 2) and to 1.09± 0.81 (visit 3) (p< 0.001). At the end of the study, 127 (43.79%) patients were well controlled (ACQ-7 score < 0.75).Conclusion: This observational study demonstrates the effectiveness and safety of extrafine fixed combination of BDP/FF (100/6 μg) pMDI in Romanian adult asthma patients uncontrolled with non-extrafine medication in a real-world setting, leading to clinically and statistically improvements in asthma control and pulmonary function.Keywords: asthma, ACQ-7, symptoms, ICS/LABA, maintenance and reliever therapy, MART |
| first_indexed | 2024-12-11T01:10:10Z |
| format | Article |
| id | doaj.art-b512e64eb44045cb9d33ed009eb3167e |
| institution | Directory Open Access Journal |
| issn | 1178-6965 |
| language | English |
| last_indexed | 2024-12-11T01:10:10Z |
| publishDate | 2022-07-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Journal of Asthma and Allergy |
| spelling | doaj.art-b512e64eb44045cb9d33ed009eb3167e2022-12-22T01:26:05ZengDove Medical PressJournal of Asthma and Allergy1178-69652022-07-01Volume 1591993376455Assessment of Symptoms Control, Pulmonary Function and Related Quality of Life in Asthmatic Patients Treated with Extrafine Beclomethasone Dipropionate/Formoterol Fumarate 100/6 μg pMDI: Results of a Multicenter Observational Study in Romania (ALFRESCO Study)Ulmeanu RBloju SVittos ORuxandra Ulmeanu,1 Sebastian Bloju,2 Oana Vittos3 1Postgraduate Training School of the Romanian Society of Pulmonology; Bronchoscopy Department - Institute of Pulmonology “Marius Nasta”, Bucharest, Romania; 2Medical Department, Chiesi Romania, Bucharest, Romania; 3Clinical Research Department, Medone Research, Bucharest, RomaniaCorrespondence: Oana Vittos, Clinical Research Department, Medone Research, 18, Alexandr Sergheevici Puskin Street, District 1, Bucharest, 011996, Romania, Tel +40 21 311 11 05, Fax +40 21 311 11 06, Email toanaoana@medone.roIntroduction: Asthma treatment guidelines advocate the use of long-acting beta2-agonists (LABA) in addition to inhaled corticosteroids (ICS) in patients whose asthma is uncontrolled by ICS alone. This is the first study done in Romania, which collected the real-world data on the effects of Foster® (extrafine beclomethasone dipropionate/formoterol fumarate BDP/FF in a pressurized metered-dose inhaler pMDI 100/6 μg formulation) in adult asthmatic population.Objective: We aimed to assess the asthma symptoms control, pulmonary function and quality of life parameters in a heterogeneous Romanian asthmatic adult outpatient population, treated with extrafine BDP/FF 100/6 μg pMDI.Methods: This was a prospective, multicenter, observational study involving 30 pulmonologists randomly selected from the Romanian healthcare system, which did not declare any competing interests. Recruitment period was Oct 2018 - Feb 2019, while the patients’ observational period was 24 weeks. The study included poorly controlled and uncontrolled adult asthma outpatients treated with non-extrafine formulations medication, for which the treatment indication, according to Global Initiative for Asthma (GINA) 2018, was the use of an ICS-LABA combination. The study collected demographic data, smoking habits, comorbidities, data regarding asthma diagnosis, the evolution of asthma symptoms, spirometry, Asthma Control Questionnaire (ACQ-7) scoring test, current and concomitant treatment.Results: Of 302 included patients, 290 completed the study. Pulmonary function parameters assessed during the trial (forced expiratory volume in one second - FEV1 and forced vital capacity - FVC) showed a significant improvement versus baseline (p< 0.001). ACQ-7 score decreased significantly from 3.09± 0.83 (visit 1) to 1.56± 0.89 (visit 2) and to 1.09± 0.81 (visit 3) (p< 0.001). At the end of the study, 127 (43.79%) patients were well controlled (ACQ-7 score < 0.75).Conclusion: This observational study demonstrates the effectiveness and safety of extrafine fixed combination of BDP/FF (100/6 μg) pMDI in Romanian adult asthma patients uncontrolled with non-extrafine medication in a real-world setting, leading to clinically and statistically improvements in asthma control and pulmonary function.Keywords: asthma, ACQ-7, symptoms, ICS/LABA, maintenance and reliever therapy, MARThttps://www.dovepress.com/assessment-of-symptoms-control-pulmonary-function-and-related-quality--peer-reviewed-fulltext-article-JAAasthmaacq-7symptomsics/labamaintenance and reliever therapymart. |
| spellingShingle | Ulmeanu R Bloju S Vittos O Assessment of Symptoms Control, Pulmonary Function and Related Quality of Life in Asthmatic Patients Treated with Extrafine Beclomethasone Dipropionate/Formoterol Fumarate 100/6 μg pMDI: Results of a Multicenter Observational Study in Romania (ALFRESCO Study) Journal of Asthma and Allergy asthma acq-7 symptoms ics/laba maintenance and reliever therapy mart. |
| title | Assessment of Symptoms Control, Pulmonary Function and Related Quality of Life in Asthmatic Patients Treated with Extrafine Beclomethasone Dipropionate/Formoterol Fumarate 100/6 μg pMDI: Results of a Multicenter Observational Study in Romania (ALFRESCO Study) |
| title_full | Assessment of Symptoms Control, Pulmonary Function and Related Quality of Life in Asthmatic Patients Treated with Extrafine Beclomethasone Dipropionate/Formoterol Fumarate 100/6 μg pMDI: Results of a Multicenter Observational Study in Romania (ALFRESCO Study) |
| title_fullStr | Assessment of Symptoms Control, Pulmonary Function and Related Quality of Life in Asthmatic Patients Treated with Extrafine Beclomethasone Dipropionate/Formoterol Fumarate 100/6 μg pMDI: Results of a Multicenter Observational Study in Romania (ALFRESCO Study) |
| title_full_unstemmed | Assessment of Symptoms Control, Pulmonary Function and Related Quality of Life in Asthmatic Patients Treated with Extrafine Beclomethasone Dipropionate/Formoterol Fumarate 100/6 μg pMDI: Results of a Multicenter Observational Study in Romania (ALFRESCO Study) |
| title_short | Assessment of Symptoms Control, Pulmonary Function and Related Quality of Life in Asthmatic Patients Treated with Extrafine Beclomethasone Dipropionate/Formoterol Fumarate 100/6 μg pMDI: Results of a Multicenter Observational Study in Romania (ALFRESCO Study) |
| title_sort | assessment of symptoms control pulmonary function and related quality of life in asthmatic patients treated with extrafine beclomethasone dipropionate formoterol fumarate 100 6 mu g pmdi results of a multicenter observational study in romania alfresco study |
| topic | asthma acq-7 symptoms ics/laba maintenance and reliever therapy mart. |
| url | https://www.dovepress.com/assessment-of-symptoms-control-pulmonary-function-and-related-quality--peer-reviewed-fulltext-article-JAA |
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