Managing Small Airways Dysfunction in COPD Patients in Real Life Under Fixed Triple Combination of Beclomethasone/Formoterol/Glycopyrronium: The MASCOT Real World Evidence Study
Year: 2025
Type: article
Abstract: Athena Gogali,1 Konstantinos Kostikas,1 Christos Kyriakopoulos,1 Dimitrios Potonos,1 Konstantinos Porpodis,2 Ioanna Tsiouprou,2 Evangelia Fouka,3 Stavros Tryfon,3 Efthymia Papadopoulou,3 Maria Kipourou,4 Konstantinos Katsoulis4 1Respiratory Medicine Department, University of Ioannina, Ioannina, Greece; 2Pulmonology Department, G. Papanikolaou Hospital, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece; 3Pulmonology Department, General Hospital of Thessaloniki “G. Papanikolaou”, Thessaloniki, Greece; 4Pulmonology Department, 424 Army General Hospital, Thessaloniki, GreeceCorrespondence: Konstantinos Kostikas, Respiratory Medicine Department, University of Ioannina, Thessaloniki, Greece, Email [email protected]: 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.Keywords: small airways, oscillometry, COPD, triple therapy
Authors: Gogali A, Kostikas K, Kyriakopoulos C, Potonos D, Porpodis K, Tsiouprou I, Fouka E, Tryfon S, Papadopoulou E, Kipourou M, Katsoulis K
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7030001946
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