Effect on Asthma Control and Quality of Life in Asthma with Pre-bronchodilator Airflow Limitation prior to Initiation of Fixed Triple Therapy Consisting of Beclometasone Dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/G): Six-Month Follow-up of the TriMaximize Study

Background: A post-bronchodilator FEV₁/FVC ratio of less than 0.70 (FEV1/FVC<0.7) is the spirometric criteria for airflow limitation. This measure is simple and independent of reference values, and it has been used in many clinical studies. On the other hand, real-world studies observed that a post-bronchodilator test was not systematically performed at the initiation of a new therapy in asthma patients and that most lung function measurements are assessed at pre-bronchodilator levels. Therefore, the impact of BDP/FF/G on asthma control and Health-Related Quality of Life (HRQoL) in asthma patients with FEV₁/FVC<0.7 remains to be assessed in a real-world setting.

Methods: TriMaximize observes patients with asthma in a period of 1-3 years after being prescribed BDP/FF/G. Patients were recruited at 125 sites in DE, UK, AT, DK, FR and ES. Pre-bronchodilator lung function was assessed by spirometry and body plethysmography. Asthma control was evaluated by the Asthma Control Test (ACT) and HRQoL was measured by Mini Asthma Quality of Life Questionnaire (Mini AQLQ).

Results: This analysis included 321 patients on BDP/FF/G 87/5/9 μg (female 58.6%, 59 years). The majority (79,8%) were on prior ICS/LABA (open or fixed) treatment or 20.2% on ICS/LABA/LAMA (open or fixed). At the beginning of treatment, a total of 159 (49.5%) patients had an FEV1/FVC<0.7 and 162 (50.5.%) had an FEV₁/FVC≥0.7. Mean ACT score was 14.4 points at baseline and did not differ between patients with impaired FEV₁/FVC<0.7 (14.4 points) or normal FEV₁/FVC≥0.7 (14.4 points). Overall, the mean ACT improved to 4.1 points after six months. Similar improvements of 4.3 points in the FEV₁/FVC<0.7 group and 3.9 points in the FEV₁/FVC≥0.7 were observed (between groups p=0.3849). In both groups the minimal clinically important difference (MCID) for ACT of 3 points was exceeded. Mean Mini AQLQ at baseline was 4.3 points (4.3 points in patients with FEV₁/FVC<0.7 and 4.2 points in FEV₁/FVC≥0.7). After six months, mean Mini AQLQ in each group increased by 0.8 (p<0.0001) points, exceeding the MCID for the Mini AQLQ of 0.5 points.

Conclusion: Significant improvement in asthma control and health-related quality of life was observed after switching to BDP/FF/G in asthma patients including the population with pre-bronchodilator FEV₁/FVC<0.7 at the start of the treatment.

Publication History

Article published online:
18 March 2025