{"title":"倍氯米松/福莫特罗/甘溴铵固定三联用药治疗COPD患者小气道功能障碍：MASCOT真实世界证据研究","authors":"Athena Gogali, Konstantinos Kostikas, Christos Kyriakopoulos, Dimitrios Potonos, Konstantinos Porpodis, Ioanna Tsiouprou, Evangelia Fouka, Stavros Tryfon, Efthymia Papadopoulou, Maria Kipourou, Konstantinos Katsoulis","doi":"10.2147/COPD.S513350","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>The efficacy of the fixed extrafine combination of beclomethasone/formoterol/glycopyrronium (BDP/FF/G 87/5/9 μg) has been evaluated in randomized controlled trials of patients with chronic obstructive pulmonary disease (COPD). However, only few data exist on its effectiveness on small airways dysfunction (SAD).</p><p><strong>Methods: </strong>The MASCOT (MAnaging Small airways dysfunction in COPD patients in real life on the fixed Triple combination of BDP/FF/G 87/5/9 μg pMDI) prospective observational study evaluated the effectiveness of this combination on SAD in a period of 4 weeks, after direct switch from long-acting β<sub>2</sub>-agonists (LABA) and long-acting muscarinic antagonists (LAMA) in COPD patients with SAD (forced expiratory flow at 25-75% of the vital capacity, FEF25-75% <60% predicted). The primary endpoint was improvement in R5-19 in oscillometry; secondary endpoints included other oscillometry parameters, lung function and health status (COPD assessment test-CAT, Saint-George's Respiratory Questionnaire-SGRQ).</p><p><strong>Results: </strong>Between May 2022 and July 2023 we recruited 93 COPD patients (mean age 68.5 years, 82% men) with forced expiratory volume in 1 second (FEV<sub>1</sub>, mean ± SD) 1.53 ± 0.47L (53.4 ± 14.5% predicted) and small airways dysfunction (FEF25-75% predicted 27.7 ± 15.4%). We observed statistically significant improvement in R5-19 between baseline (V1) and follow-up (V2) visits [median (IQR) V2 0.70 (0.41-1.10) vs V1 0.90 (0.60-1.83); mean change (95% CI) -0.49, -0.66 to -0.33 cmH<sub>2</sub>O/L/sec, p < 0.0001). There were improvements in multiple parameters, including FEF25-75% (3.43, 1.20% to 5.66%, p = 0.0005), FEV<sub>1</sub> (0.142, 0.078 to 0.205 L, p < 0.0001) and RV/TLC (-6.09, -9.61% to -2,56% predicted, p < 0.0001), as well as improvement in CAT score -4.09 (-5.09 to -3.08) και SGRQ total score (-8.75, -11.58 to -5.93 points, p < 0.0001).</p><p><strong>Conclusion: </strong>Extrafine triple therapy improved SAD and spirometric parameters, leading to improvement in health status at 4 weeks. These results need to be confirmed in longer studies.</p>","PeriodicalId":48818,"journal":{"name":"International Journal of Chronic Obstructive Pulmonary Disease","volume":"20 ","pages":"1651-1663"},"PeriodicalIF":2.7000,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12108956/pdf/","citationCount":"0","resultStr":"{\"title\":\"Managing Small Airways Dysfunction in COPD Patients in Real Life Under Fixed Triple Combination of Beclomethasone/Formoterol/Glycopyrronium: The MASCOT Real World Evidence Study.\",\"authors\":\"Athena Gogali, Konstantinos Kostikas, Christos Kyriakopoulos, Dimitrios Potonos, Konstantinos Porpodis, Ioanna Tsiouprou, Evangelia Fouka, Stavros Tryfon, Efthymia Papadopoulou, Maria Kipourou, Konstantinos Katsoulis\",\"doi\":\"10.2147/COPD.S513350\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>The efficacy of the fixed extrafine combination of beclomethasone/formoterol/glycopyrronium (BDP/FF/G 87/5/9 μg) has been evaluated in randomized controlled trials of patients with chronic obstructive pulmonary disease (COPD). However, only few data exist on its effectiveness on small airways dysfunction (SAD).</p><p><strong>Methods: </strong>The MASCOT (MAnaging Small airways dysfunction in COPD patients in real life on the fixed Triple combination of BDP/FF/G 87/5/9 μg pMDI) prospective observational study evaluated the effectiveness of this combination on SAD in a period of 4 weeks, after direct switch from long-acting β<sub>2</sub>-agonists (LABA) and long-acting muscarinic antagonists (LAMA) in COPD patients with SAD (forced expiratory flow at 25-75% of the vital capacity, FEF25-75% <60% predicted). The primary endpoint was improvement in R5-19 in oscillometry; secondary endpoints included other oscillometry parameters, lung function and health status (COPD assessment test-CAT, Saint-George's Respiratory Questionnaire-SGRQ).</p><p><strong>Results: </strong>Between May 2022 and July 2023 we recruited 93 COPD patients (mean age 68.5 years, 82% men) with forced expiratory volume in 1 second (FEV<sub>1</sub>, mean ± SD) 1.53 ± 0.47L (53.4 ± 14.5% predicted) and small airways dysfunction (FEF25-75% predicted 27.7 ± 15.4%). We observed statistically significant improvement in R5-19 between baseline (V1) and follow-up (V2) visits [median (IQR) V2 0.70 (0.41-1.10) vs V1 0.90 (0.60-1.83); mean change (95% CI) -0.49, -0.66 to -0.33 cmH<sub>2</sub>O/L/sec, p < 0.0001). There were improvements in multiple parameters, including FEF25-75% (3.43, 1.20% to 5.66%, p = 0.0005), FEV<sub>1</sub> (0.142, 0.078 to 0.205 L, p < 0.0001) and RV/TLC (-6.09, -9.61% to -2,56% predicted, p < 0.0001), as well as improvement in CAT score -4.09 (-5.09 to -3.08) και SGRQ total score (-8.75, -11.58 to -5.93 points, p < 0.0001).</p><p><strong>Conclusion: </strong>Extrafine triple therapy improved SAD and spirometric parameters, leading to improvement in health status at 4 weeks. These results need to be confirmed in longer studies.</p>\",\"PeriodicalId\":48818,\"journal\":{\"name\":\"International Journal of Chronic Obstructive Pulmonary Disease\",\"volume\":\"20 \",\"pages\":\"1651-1663\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2025-05-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12108956/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Chronic Obstructive Pulmonary Disease\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/COPD.S513350\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"RESPIRATORY SYSTEM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Chronic Obstructive Pulmonary Disease","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/COPD.S513350","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
Managing Small Airways Dysfunction in COPD Patients in Real Life Under Fixed Triple Combination of Beclomethasone/Formoterol/Glycopyrronium: The MASCOT Real World Evidence Study.
Introduction: The efficacy of the fixed extrafine combination of beclomethasone/formoterol/glycopyrronium (BDP/FF/G 87/5/9 μg) has been evaluated in randomized controlled trials of patients with chronic obstructive pulmonary disease (COPD). However, only few data exist on its effectiveness on small airways dysfunction (SAD).
Methods: The MASCOT (MAnaging Small airways dysfunction in COPD patients in real life on the fixed Triple combination of BDP/FF/G 87/5/9 μg pMDI) prospective observational study evaluated the effectiveness of this combination on SAD in a period of 4 weeks, after direct switch from long-acting β2-agonists (LABA) and long-acting muscarinic antagonists (LAMA) in COPD patients with SAD (forced expiratory flow at 25-75% of the vital capacity, FEF25-75% <60% predicted). The primary endpoint was improvement in R5-19 in oscillometry; secondary endpoints included other oscillometry parameters, lung function and health status (COPD assessment test-CAT, Saint-George's Respiratory Questionnaire-SGRQ).
Results: Between May 2022 and July 2023 we recruited 93 COPD patients (mean age 68.5 years, 82% men) with forced expiratory volume in 1 second (FEV1, mean ± SD) 1.53 ± 0.47L (53.4 ± 14.5% predicted) and small airways dysfunction (FEF25-75% predicted 27.7 ± 15.4%). We observed statistically significant improvement in R5-19 between baseline (V1) and follow-up (V2) visits [median (IQR) V2 0.70 (0.41-1.10) vs V1 0.90 (0.60-1.83); mean change (95% CI) -0.49, -0.66 to -0.33 cmH2O/L/sec, p < 0.0001). There were improvements in multiple parameters, including FEF25-75% (3.43, 1.20% to 5.66%, p = 0.0005), FEV1 (0.142, 0.078 to 0.205 L, p < 0.0001) and RV/TLC (-6.09, -9.61% to -2,56% predicted, p < 0.0001), as well as improvement in CAT score -4.09 (-5.09 to -3.08) και SGRQ total score (-8.75, -11.58 to -5.93 points, p < 0.0001).
Conclusion: Extrafine triple therapy improved SAD and spirometric parameters, leading to improvement in health status at 4 weeks. These results need to be confirmed in longer studies.
期刊介绍：
An international, peer-reviewed journal of therapeutics and pharmacology focusing on concise rapid reporting of clinical studies and reviews in COPD. Special focus will be given to the pathophysiological processes underlying the disease, intervention programs, patient focused education, and self management protocols. This journal is directed at specialists and healthcare professionals
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