Achievability and Durability of Clinical Remission with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Asthma in The United States: A 24-Month Real-World Analysis

Presenter:Stephen G Noorduyn.

Clinical remission (CR) has emerged as a treatment goal in asthma, with post-hoc analyses of the Phase 3 CAPTAIN trial indicating that it can be achieved with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI). This retrospective, physician panel-based chart review assessed CR in US adults with asthma who initiated FF/UMEC/VI between 9/9/2020 and 31/8/2023 and remained on treatment for ≥12 months. CR at 12, 18 and 24 months was defined as requiring no oral corticosteroid use, no exacerbations (defined as those requiring systemic corticosteroids, an emergency department or urgent care centre visit for asthma, or an inpatient stay for asthma), well-controlled asthma (ACT score ≥20 or ACQ-6 score <1.5), and either optimised lung function (FEV₁ ≥100 mL improvement from baseline or FEV₁ ≥80% predicted) or stabilised lung function (no worsening in FEV₁ or FEV₁ % predicted from baseline). Among 310 patients (mean age 40.5 years; 57.1% female), 33.9% achieved CR with optimised lung function at 12 months. Among those with extended follow-up, CR was maintained in 93.5% at 18 months and 92.3% at 24 months. Of patients without CR at 12 months, 19.8% and 19.4% achieved CR at 18 months, while 19.1% and 20.9% achieved CR at 24 months in the optimised and stabilised Lung Function (LF) groups, respectively. Overall, CR was achieved by approximately one-third of patients at 12 months and was maintained in most patients with available longer-term follow-up.

Achievability of Clinical Remission in Patients with Asthma Stepping up to Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) or Initiating FF/UMEC/VI as Initial Maintenance Therapy: Results of A Real-World US Study

Presenter:Stephen G Noorduyn.

Clinical remission (CR) has been reported as achievable with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in post-hoc analyses of the Phase 3 CAPTAIN trial. This real-world analysis assessed CR among US adults with asthma initiating FF/UMEC/VI as initial maintenance therapy (IMT) or as step-up therapy after prior ICS-containing treatment.

In this retrospective, physician panel-based chart review, 310 adults initiated FF/UMEC/VI between 9/9/2020 and 31/8/2023 and continued treatment for ≥12 months; 109 received IMT and 201 step-up therapy. CR at 12 months required no oral corticosteroid use, no exacerbations (defined as an exacerbation requiring systemic corticosteroids, an emergency department or urgent care centre visit for asthma, or an inpatient stay for asthma, well-controlled asthma (ACT score ≥20 or ACQ-6 score <1.5), and either optimised lung function (FEV₁ ≥100 mL improvement from baseline or FEV₁ ≥80% predicted) or stabilised lung function (no worsening in FEV₁ or FEV₁% predicted from baseline). An optimised-LF CR profile was observed in 41.3% of IMT versus 29.9% of step-up patients. Individual components included no exacerbations in 72.5% IMT vs 59.7% step-up, well-controlled asthma in 50.5% IMT vs 48.8% step-up, and optimised LF in 88.1% IMT vs 82.1% step-up, respectively.

Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate Effects on Clinical Remission in Inadequately Controlled Asthma: Post Hoc Analyses of KALOS and LOGOS Studies

Presenter:David J. Jackson.

Uncontrolled asthma was the setting for evaluating whether adding glycopyrronium to budesonide/formoterol could increase the likelihood of achieving clinical remission. These post hoc pooled analyses of the Phase 3 KALOS and LOGOS studies included participants aged ≥12 years (N=4311) randomised to BGF 28.8 (320/28.8/10 µg), BGF 14.4 (320/14.4/10 µg), or BFF_Combined (BFF_A and BFF_S), twice daily for 24 to 52 weeks. Clinical remission required no systemic corticosteroid use or severe exacerbations, ACQ-5 ≤1.5, ≤1 or ≤0.75, and trough FEV₁ ≥100 mL at Week 24 or 52. With BGF 28.8 versus BFF_Combined, remission rates at ACQ-5 ≤1.5 were 29.8% versus 20.6% at 24 weeks and 27.6% versus 17.2% at 52 weeks; at ACQ-5 ≤0.75, rates were 14.8% versus 9.7% and 14.0% versus 7.9%, respectively. The corresponding odds ratios for BGF 28.8 versus BFF_Combined were 1.76 (1.44, 2.15) and 2.05 (1.62, 2.58) for ACQ-5 ≤1.5, and 1.92 (1.42, 2.60) and 2.45 (1.73, 3.48) for ACQ-5 ≤0.75, at 24 and 52 weeks, respectively. BGF 14.4 showed similar directional trends. Overall, BGF 28.8 triple therapy improved the likelihood of achieving clinical remission compared with BFF dual therapy in participants with uncontrolled asthma.

Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate Effects on Lung Function and Asthma Exacerbations by Persistent Airflow Limitation Status: Post Hoc Analyses of KALOS and LOGOS Studies

Presenter:Prof. Alberto Papi.

Persistent airflow limitation (PAL) in asthma was associated with poorer disease control, lung function decline and exacerbations, underscoring the clinical importance of evaluating treatment efficacy according to PAL status. This pooled post hoc analysis of KALOS and LOGOS included participants aged ≥12 years (N=4311) with inadequately controlled asthma, randomised to budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) 28.8 (320/28.8/10 µg), BGF 14.4 (320/14.4/10 µg), budesonide/formoterol fumarate dihydrate Aerosphere® MDI (BFFA; 320/10 µg), or Symbicort® (BFF_S; 320/9 µg) twice daily for 24–52 weeks. PAL was defined as post-albuterol FEV₁/FVC <70% at Visits 2 and 3. Compared with BFF_Combined, both BGF doses showed directionally consistent improvements in trough FEV₁ and FEV₁ AUC₀–₃ in participants with and without PAL. BGF 28.8 also reduced severe exacerbation rates and increased the proportion of ACQ-7 responders, with similar trends across PAL groups. Overall, the benefits of BGF 28.8 over BFF_Combined, including improved lung function and reduced severe exacerbation rates, were observed irrespective of PAL status.

Differences Between Cough Variant Asthma and Classic Bronchial Asthma in Terms of Feno Airway Inflammation

Presenter:Yuanpeng Li.
Cough-variant asthma (CVA) and classic bronchial asthma (BA) share airway hyperresponsiveness, but the extent and distribution of airway inflammation may differ between the two phenotypes. This retrospective study analysed 217 patients with chronic cough (≥8 weeks) or cough with wheezing evaluated between January 2023 and January 2025; after excluding alternative diagnoses, 76 patients with airway hyperresponsiveness were classified as CVA (n=48) or BA (n=28). FeNO50 and FeNO200 were assessed as markers of large- and small-airway inflammation, respectively. Elevated FeNO50 and/or FeNO200 occurred less frequently in CVA than BA (41.7% vs. 75.0%, P<0.01). Within CVA, FeNO200 elevation was more frequent than FeNO50 elevation (80.0% vs. 50.0%, P<0.05), whereas BA showed the opposite pattern (57.1% vs. 85.7%, P<0.05). Overall, CVA showed lower airway inflammatory burden with greater small-airway involvement, while BA demonstrated predominantly large-airway inflammation. FeNO stratification may aid in differentiating asthma phenotypes and guiding individualized treatment.

Efficacy of Budesonide/Formoterol/Glycopyrronium in Indian Patients with Uncontrolled Asthma: An Interim Analysis of a Prospective, Single-Center Study

Presenter:Indranil Halder.

A significant proportion of patients with asthma remain uncontrolled despite ICS/LABA therapy, and the GINA 2023 report recommends adding a long-acting muscarinic antagonist (LAMA) in this setting. However, real-world evidence for budesonide/formoterol/glycopyrronium triple therapy remains limited. This open-label, prospective, single-center study at a tertiary hospital in eastern India evaluated the effects of single-inhaler budesonide/formoterol/glycopyrronium on asthma control and lung function in patients with uncontrolled asthma (ACQ-5 >1.5) despite ICS/LABA therapy. Patients were stepped up to budesonide/formoterol/glycopyrronium (200/6/12.5 µg) pMDI (2 puffs twice daily) with a spacer, with changes in ACQ-5 and spirometry, assessed at Week 12. In this interim analysis evaluated 72 patients (mean age 42.36 ± 13.60 years; 76.39% female).. Mean ACQ-5 decreased from 2.62 ± 0.75 to 1.27 ± 0.74 (mean change 1.35; p < 0.001), while FEV₁, FVC and FEF25-75 increased by 1.10 L, 0.99 L and 1.66 L/s, respectively (all p < 0.001). No SAEs or AEs leading to discontinuation were reported. Overall, these findings support triple therapy as a step-up option for patients with uncontrolled asthma despite ICS/LABA treatment.

Equitable Performance of an AI-Based Digital Biomarker for Early Prediction of Childhood Asthma Exacerbations across Socioeconomic Strata

Presenter: CHUNG-IL WI.

Socioeconomic status (SES) may affect the distribution of childhood asthma, raising the question of whether tools for early risk prediction perform consistently across socioeconomic groups. This retrospective cohort study evaluated whether SES modified the predictive performance of a natural language processing (NLP)-derived digital biomarker based on electronic health record data, which uses validated asthma phenotypes at age 3—Predetermined Asthma Criteria (PAC) and Asthma Predictive Index (API)—to identify children at increased risk of future asthma exacerbations (AE). Among 7,390 children (49% female; 82% White) in the Mayo Clinic Birth Cohort, SES at age 3 was classified using the individual-level HOUSES index in quartiles. Lower SES was associated with a higher prevalence of PAC+API-defined asthma (14% in Q1 vs. 10% in Q4; p<0.001), but SES was not independently associated with AE among children with asthma. Across HOUSES quartiles, the NLP-defined PAC+API phenotype consistently identified children with higher AE rates than PAC-only or API-only phenotypes (adjusted hazard ratios 2.22–2.97; p<0.05), except in Q2, with no evidence of SES-related effect modification (interaction p=0.68). These findings indicate consistent predictive performance of the NLP-derived biomarker across SES strata, supporting its potential for equitable early pediatric asthma risk stratification.

Late Breaking Abstract - Digital Clinical Decision Support for Occupational Asthma: A Validated Prediction Model-Based Mobile Application

Presenter: Eva Suarthana.

Limited access to the reference-standard specific inhalation challenge (SIC) remains a significant challenge in diagnosing occupational asthma (OA) triggered by low- or high-molecular-weight agents. This study developed and validated non-SIC-based logistic regression models incorporating patient history and commonly available diagnostic tests to identify OA defined by a positive SIC. Retrospective data from Canadian centres were used for model development, with external validation in populations from Canada, Finland, Poland, Turkey, and the United Kingdom. The clinical interview model showed fair discrimination (AUC ≈0.65–0.75), while adding diagnostic tests improved predictive performance. In particular, combining clinical interview variables with nonspecific bronchial hyperresponsiveness (NSBHR) and serial peak expiratory flow (PEF) measurements provided stronger discrimination, with the combination of clinical interview and serial PEF achieving an AUC of ≈0.80–0.85 in the development set. The final models demonstrated good calibration and internal validity, with consistent findings across external validation populations. The validated models were subsequently implemented as an online calculator and mobile application to estimate OA probability and support referral or diagnostic decisions when SIC is unavailable or unnecessary.

Real-World Asthma: AI Management and Digital Follow-Up Improve Lung Function

Presenter: Yuqing Li.

Longitudinal real-world evidence on whether AI-supported asthma management improves clinical outcomes remains limited. This study followed asthma patients receiving medium- to high-dose inhaled corticosteroids (ICS) who participated in an AI-supported programme incorporating symptom tracking, medication guidance, tailored education, and AI-assisted nurse follow-up through a mobile app/WeChat mini-program. Spirometry and Asthma Control Test (ACT) scores were assessed at baseline (T1) and within 12 months (T2). Among 200 patients with valid paired spirometry, median FEV₁ increased from 2.25 L (IQR 1.65–3.07) to 2.52 L (1.74–3.27), with a median ΔFEV₁ of 50 mL (IQR −30 to 262.5). Clinically meaningful improvement occurred in 32.5% (65/200) for ΔFEV₁ ≥200 mL and 39.0% (78/200) for ΔFEV₁%pred ≥5%. Median ΔFEV₁%pred was 1.84% (IQR −1.36 to 8.73). ACT improved from 20 (17–23) to 21 (19–23), with a median ΔACT of 1 (IQR −2 to 4). In this real-world cohort, AI-supported management was associated with improvements in lung function and symptom control.

Real-World Evidence: Assessing Baseline Characteristics and 1-Year Outcomes in GINA 4 Asthma Patients with and without Exacerbations

Presenter: Hippolyte Pernot.

A substantial proportion of patients receiving GINA Step 4 therapy remain inadequately controlled, including those without a history of severe exacerbations (SevEx). This real-world study used electronic health record data from TriNetX Dataworks to characterise disease trajectories among 16,535 patients receiving GINA Step 4 therapy during the 365-day baseline period. Patients were classified as uncontrolled with SevEx (PP1), uncontrolled with non-severe worsening (PP2), or controlled asthma (PP3). At baseline, 42.7%, 46.2%, and 11.1% were in PP1, PP2, and PP3, respectively. Despite treatment step-up, 75.7% remained uncontrolled at follow-up. Among PP1 and PP2 patients, treatment step-up occurred in 11.4% and 9.3%, ≥2 outpatient visits in 30.5% and 32.8%, and ≥3 SABA prescriptions in 67.9% and 63.4%, respectively. PP1 patients were 2.5x more likely to experience SevEx during follow-up than PP2 patients. Among PP3 patients, >50% became uncontrolled. Overall, persistent disease burden was evident across GINA Step 4 profiles, supporting an unmet need for improved asthma control irrespective of SevEx history.

Shared Decision-Making in Asthma Management: Impact of MART and AIR Implementation on Salbutamol Prescribing and Carbon Emissions in Primary Care from April 2024 to April 2025

Presenter: Meredith Donaldson.

Reducing reliance on short-acting β₂-agonists (SABAs) through Maintenance and Reliever Therapy (MART) and Anti-inflammatory Reliever (AIR) regimens may influence both asthma management and inhaler-related environmental impact. This retrospective primary care review evaluated the real-world effect of shared-decision implementation of MART and AIR on salbutamol prescribing and associated carbon emissions over 12 months, from April 2024 to April 2025. Practice prescribing data were assessed using the NHS carbon footprint metric (OpenPrescribing), alongside patient-supported transitions to MART or AIR where appropriate. Over 12 months, salbutamol prescriptions decreased by 33%, from 430 to 290, while estimated carbon emissions decreased by 42%, from 7,531 kgCO₂e to 4,396 kgCO₂e. The findings indicate that shared decision-making alongside implementation of MART and AIR was associated with reductions in salbutamol prescribing and estimated carbon emissions in routine primary care. These observations support the potential value of combining patient engagement with guideline-based asthma management strategies to address both clinical practice and environmental sustainability.

Short-Acting β2-Agonists (SABA) Monotherapy and Associated Factors Among Patients with Asthma -A Report from the Swedish National Airway Register

Presenter: Stina Selberg.

Despite increasing emphasis on inhaled corticosteroids (ICS), SABA monotherapy remains a treatment gap in asthma management and may be linked to inadequate disease control. This study examined changes in SABA monotherapy prevalence between 2019 and 2022, and factors associated with its use in 2022 among 125,362 adults with asthma identified from the Swedish National Airway Register. SABA monotherapy was defined as dispensed SABA without any ICS dispensation. Its prevalence decreased from 7.9% in 2019 to 6.0% in 2022. Previous SABA monotherapy was most strongly associated with SABA monotherapy in 2022 (adjRR 3.69; 95% 3.48-3.92), while smoking (1.27, 1.18-1.37), uncontrolled asthma (1.30, 1.20-1.41), no ACT assessment (1.25, 1.16-1.34), and no spirometry assessment (1.10, 1.03-1.16) were also associated factors. Previous ICS use (0.57, 0.54-0.61) and COVID-19 hospitalization between 2020-2022 (0.79, 0.65-0.97) were associated with lower risk. Thus, although SABA monotherapy declined, it persisted particularly among patients with poorer asthma control, smokers, patients with poorer asthma control, and those without recommended objective assessments such as ACT or spirometry.

Very-Low-Dose Budesonide-Formoterol Maintenance and Reliever Therapy (MART) versus Fixed-Low-Dose Budesonide-Formoterol Plus as-Needed Salbutamol in Children 6-11 Years with Asthma: A Randomized Controlled Trial.

Presenter: Sathya Srivatsav.

Evidence supporting very-low-dose inhaled corticosteroid/long-acting β₂-agonist (ICS/LABA) Maintenance and Reliever Therapy (MART) in children aged 6–11 years requiring Step 3 treatment remains limited. This open-label, non-inferiority randomized controlled trial evaluated very-low-dose MART versus fixed-low-dose ICS/LABA plus as-needed SABA in newly diagnosed children aged 6–11 years requiring Step 3 therapy according to GINA guidelines. Of 98 randomized children, 94 (47 in each group) completed 3 months of follow-up; mean (SD) age was 8 (1.6) years and 71 (72.5%) were male. Change in ACQ-5 scores was similar with MART and fixed-dose ICS/LABA [1.61 (0.99) vs 1.59 (0.89); p=0.89]. The between-group mean difference was 0.02 [95% CI (-0.37 to 0.42)], remaining within the prespecified non-inferiority limit of 0.5. No significant differences were observed in FEV1 change, exacerbations, OCS use, emergency visits, or hospitalizations. Very-low-dose MART was therefore non-inferior to fixed-low-dose ICS/LABA plus as-needed SABA over 3 months.

ERS Congress 2026, 5-9 September, Barcelona, Spain