Managing Small Airways Dysfunction in COPD Patients in Real Life Under Fixed Triple Combination of Beclomethasone/Formoterol/Glycopyrronium: The MASCOT Real World Evidence Study

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