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P292 Effectiveness of extrafine single-inhaler triple therapy on asthma control and quality of life one year post treatment according to patients’ smoking status: the triangle study

thoraxjnl · 2025-11-02 · canonical JSON source

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Introduction The efficacy of extrafine single-inhaler triple therapy (efSITT), with beclomethasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) in asthma has been assessed in randomized controlled trials, excluding though both current and ex-smokers with a smoking history of ≥ 10 pack years. The Triangle study provides real-world evidence of efSITT’s effectiveness in asthma patients in Greece.Aims and objectives This observational study aims to assess therapy pathways and health-related outcomes of BDP/FF/G in moderate-to-severe asthma patients, previously treated with medium dose ICS+LABA or open triple therapy, including patients across all smoking statuses.Methods This interim analysis includes 333 patients who received treatment with BDP/FF/G (87/5/9 µg) for 48 weeks. The co-primary objectives are assessment of asthma control (ACT) and description of treatment pathways. Secondary objectives include assessment of health-related quality of life (HRQoL), evaluated by AQLQ (S). Results were stratified by patients’ smoking status.Results The mean age of participants was 56.9 years, with a mean BMI of 28.6 kg/m 2 and a mean asthma duration of 11.7 years since diagnosis. Prior to switching to efSITT, 81.6% of patients were on ICS+LABA and 18.4% on ICS+LABA+LAMA. The main reasons for switching included worsening of symptoms or need for treatment escalation (72.3%), exacerbations (34.3%), deterioration of lung function (31.3%), regimen simplification or poor compliance (17.6%), and adverse effects of previous treatment (2.7%).Overall, 39.3% of patients were never smokers, 31.5% were current smokers and 29.1% ex-smokers with a history of 36.3 and 18.9 mean pack years, respectively. After 1 year of treatment, ACT score improved by more than 6 points in all groups (all p<0.05) (figure 1A). Additionally, ≥88% of patients in each group achieved the minimum clinically important difference (MCID) in ACT score (≥3-point increase).At baseline, the mean (±SD) AQLQ (S) score in the overall population was 4.4±1.0. At the 12-month follow-up, the mean change from baseline exceeded 1.5 points in all groups (p<0.05), exceeding the MCID threshold of 0.5 points.Abstract P292 Figure 1Mean of the total ACT score across the three study visits, by smoking status. The ACT score ranges from 5 (worst status) to 25 (complete control). Base: Number of patients at each visit for whom ACT was recorded (N=331, 331 and 301 respectively for each visit), p<0.05 for all comparisons. Figure1B: Mean value of the total AQLQ (S) score at the three study visits, by smoking status. The AQLQ (S) score ranges from 1 (maximal impairment) to 7 (no impairment). Base: Number of patients at each visit, with recorded AQLQ (S) (N=333, 331 and 301 respectively for each visit), p<0.05 for all comparisonsConclusions Our real-world data suggest a significant improvement in asthma control and HRQoL after switching to BDP/FF/G regardless of smoking status, enhancing our understanding on efSITT’s effectiveness in these understudied populations.