Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial
Background Only a few studies directly compared the therapeutic efficacy and safety of two pressurized metered-dose inhalers (pMDIs) in asthma. We analyzed the asthma treatment outcomes, safety, and patient preferences using formoterol/beclomethasone (FORM/BDP), a pMDI with extra-fine particles, com...
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The Korean Academy of Tuberculosis and Respiratory Diseases
2022-01-01
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| Series: | Tuberculosis and Respiratory Diseases |
| Subjects: | |
| Online Access: | http://www.e-trd.org/upload/pdf/trd-2021-0093.pdf |
| _version_ | 1798034403086041088 |
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| author | Tae-Hyun Nam Sung-Yoon Kang Sang Min Lee Tae-Bum Kim Sang Pyo Lee |
| author_facet | Tae-Hyun Nam Sung-Yoon Kang Sang Min Lee Tae-Bum Kim Sang Pyo Lee |
| author_sort | Tae-Hyun Nam |
| collection | DOAJ |
| description | Background Only a few studies directly compared the therapeutic efficacy and safety of two pressurized metered-dose inhalers (pMDIs) in asthma. We analyzed the asthma treatment outcomes, safety, and patient preferences using formoterol/beclomethasone (FORM/BDP), a pMDI with extra-fine particles, compared with formoterol/budesonide (FORM/BUD), another pMDI with non-extra-fine particles. Methods In this randomized, double-blind, double-dummy parallel group study, 40 adult asthmatics were randomized to FORM/BDP group (n=18; active FORM/BDP and placebo FORM/BUD) or FORM/BUD group (n=22; active FORM/BUD and placebo FORM/BDP). During the two visits (baseline and end of 8-week treatment), subjects were asked to answer questionnaires including asthma control test (ACT), asthma control questionnaires (ACQ), and Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA). Lung function, compliance with inhaler, and inhaler-handling skills were also assessed. Results Ten subjects in the FORM/BDP group and 14 in the FORM/BUD group completed follow-up visits. ACT, ACQ, QLQAKA (a primary outcome), and adverse events did not differ between two groups. We found that the increase in forced expiratory volume in 1 second/forced vital capacity and forced expiratory flow at 25% to 75% of the pulmonary volume in the FORM/BDP group was higher than in the FORM/BUD group. Regarding preference, subjects responded that the flume velocity of FORM/BDP was higher, but more adequate than that of FORM/BUD. They also answered that FORM/BDP reached the trachea and bronchus and irritated them significantly more than FORM/BUD. Conclusion The use of pMDI with extra-fine particles may relieve small airway obstruction more than the one with non-extra-fine particles despite no significant differences in overall treatment outcomes. Some asthmatics have a misconception about the adequacy of high flume velocity of pMDIs. |
| first_indexed | 2024-04-11T20:43:51Z |
| format | Article |
| id | doaj.art-cbd982e88896421999cbfc6a580a9a4f |
| institution | Directory Open Access Journal |
| issn | 1738-3536 2005-6184 |
| language | English |
| last_indexed | 2024-04-11T20:43:51Z |
| publishDate | 2022-01-01 |
| publisher | The Korean Academy of Tuberculosis and Respiratory Diseases |
| record_format | Article |
| series | Tuberculosis and Respiratory Diseases |
| spelling | doaj.art-cbd982e88896421999cbfc6a580a9a4f2022-12-22T04:04:07ZengThe Korean Academy of Tuberculosis and Respiratory DiseasesTuberculosis and Respiratory Diseases1738-35362005-61842022-01-01851253610.4046/trd.2021.00934602Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical TrialTae-Hyun Nam0Sung-Yoon Kang1Sang Min Lee2Tae-Bum Kim3Sang Pyo Lee4 Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of KoreaBackground Only a few studies directly compared the therapeutic efficacy and safety of two pressurized metered-dose inhalers (pMDIs) in asthma. We analyzed the asthma treatment outcomes, safety, and patient preferences using formoterol/beclomethasone (FORM/BDP), a pMDI with extra-fine particles, compared with formoterol/budesonide (FORM/BUD), another pMDI with non-extra-fine particles. Methods In this randomized, double-blind, double-dummy parallel group study, 40 adult asthmatics were randomized to FORM/BDP group (n=18; active FORM/BDP and placebo FORM/BUD) or FORM/BUD group (n=22; active FORM/BUD and placebo FORM/BDP). During the two visits (baseline and end of 8-week treatment), subjects were asked to answer questionnaires including asthma control test (ACT), asthma control questionnaires (ACQ), and Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA). Lung function, compliance with inhaler, and inhaler-handling skills were also assessed. Results Ten subjects in the FORM/BDP group and 14 in the FORM/BUD group completed follow-up visits. ACT, ACQ, QLQAKA (a primary outcome), and adverse events did not differ between two groups. We found that the increase in forced expiratory volume in 1 second/forced vital capacity and forced expiratory flow at 25% to 75% of the pulmonary volume in the FORM/BDP group was higher than in the FORM/BUD group. Regarding preference, subjects responded that the flume velocity of FORM/BDP was higher, but more adequate than that of FORM/BUD. They also answered that FORM/BDP reached the trachea and bronchus and irritated them significantly more than FORM/BUD. Conclusion The use of pMDI with extra-fine particles may relieve small airway obstruction more than the one with non-extra-fine particles despite no significant differences in overall treatment outcomes. Some asthmatics have a misconception about the adequacy of high flume velocity of pMDIs.http://www.e-trd.org/upload/pdf/trd-2021-0093.pdfasthmametered-dose inhalersparticle sizetreatment outcomepreference |
| spellingShingle | Tae-Hyun Nam Sung-Yoon Kang Sang Min Lee Tae-Bum Kim Sang Pyo Lee Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial Tuberculosis and Respiratory Diseases asthma metered-dose inhalers particle size treatment outcome preference |
| title | Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial |
| title_full | Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial |
| title_fullStr | Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial |
| title_full_unstemmed | Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial |
| title_short | Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial |
| title_sort | comparison of two pmdis in adult asthmatics a randomized double blind double dummy clinical trial |
| topic | asthma metered-dose inhalers particle size treatment outcome preference |
| url | http://www.e-trd.org/upload/pdf/trd-2021-0093.pdf |
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