Time to Rethink ICS Dosing in Pursuit of Asthma Clinical Remission: High-Dose ICS/LABA May Restore Short-Term Asthma Control When Medium Doses Fail

Background/Objectives: Asthma therapy aims to achieve asthma control, defined as reduced or absent symptoms, no exacerbations and a minimized risk of future untoward outcomes imposed by either the disease or drug side effects. The study aimed to assess the effectiveness and general clinical safety of shifting from medium- to high-dose BDP/FF in a fixed-dose pMDI extra-fine combination as maintenance therapy in patients with poor asthma control despite regular use of a medium-dose fixed formulation of BDP/FF in a real-world setting. Methods: BREATH was a multicenter, noninterventional, prospective, real-world based observational study enrolling 93 patients with poor asthma control (ACQ-5 ≥ 1.5) and not meeting Global Initiative for Asthma (GINA) clinical criteria for asthma control despite regular medium-dose BDP/FF use, for whom the treating physician decided to shift to regular high-dose BDP/FF and who were followed for 12 weeks at monthly visits. Adherence/compliance with inhaler therapy, asthma exacerbations and asthma-related emergency visits/hospitalizations were monitored. Results: The overall asthma control in the study group improved significantly and progressively, with the mean ACQ-5 score decreasing from 2.8 (SD 0.7) to 0.7 (SD 0.7) points. Visit-to-visit ACQ-5 reductions were significant up to 8 weeks after study entry. The percentage of patients who demonstrated clinically significant improvement in the ACQ-5 score reached 94.4%, with 61.8% fulfilling the ACQ-5 criteria for controlled asthma (58.4% for the GINA clinical criteria). Conclusions: Shifting from medium to high doses of BDP/FF in a fixed-dose combination of pMDI and extra-fine BDP/FF in patients who remain symptomatic despite regular medium-dose BDP/FF therapy may improve short-term asthma control.