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Efficacy of Inhaler Devices in New-Onset Mild Asthma: A Randomized Blinded Multicenter Trial
1Department of Respiratory and Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No. 100 Haining Rd, Shanghai, 200080, China.
Introduction:
Low-dose inhaled corticosteroids (ICS) manage mild bronchial asthma effectively. Although pressurized metered-dose inhalers (pMDI) and dry powder inhalers (DPI) demonstrate similar efficacy in moderate-to-severe asthma, their effectiveness against mild asthma remains less established. This multicenter study evaluates the efficacy of ICS-pMDI versus ICS-DPI in newly diagnosed mild asthma.
Methods:
Patients (156) with newly diagnosed mild asthma were randomized to receive pMDI or DPI treatment for 4 weeks. Evaluations included lung function, asthma control test (ACT) scores, and blood eosinophil (EOS) counts. Data were analyzed using the full analysis set (FAS) and per-protocol set (PPS).
Results:
FAS analysis indicated that the pMDI group had significantly improved large airway parameters such as forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC). PPS analysis revealed enhanced small airway function (SAF) indicators such as forced expiratory flow at 50% of forced vital capacity (FEF50%) and forced expiratory flow at 25-75% of forced vital capacity (FEF25-75%) in the pMDI group, with no significant changes in the DPI group. The pMDI group also showed greater absolute improvement in FEV1, especially in patients with baseline small airway dysfunction (SAD) or EOS ≥ 150 cells/µL. Both groups had significantly improved ACT scores and reduced EOS counts, without significant intergroup differences. Correlation analysis revealed a positive relationship between baseline FEV1 reversibility and improvements in FEV1 and FEF25-75% in the pMDI group. Exacerbation rates and adverse events were similar between groups.
Conclusion:
A 4-week ICS-pMDI treatment may improve both large and small airway function in patients with newly diagnosed mild asthma, with comparable symptom control, inflammation reduction, and adverse event profile to ICS-DPI. Baseline SAD, elevated EOS levels, and FEV1 reversibility may predict pMDI effectiveness in improving airway function.
Clinical Trial Registration:
ChiCTR2400094311, www.chictr.org.cn .
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