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Войти в исследования Respirology (Carlton, Vic.) · 2026
Bronchodilator Drug Delivery With Pressurized Meter-Dose-Inhaler Versus Jet Nebulizer With Noninvasive-Ventilation in Acute-Exacerbation of COPD: A Randomized Controlled Pharmacokinetic Endpoint Trial.
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Raj Vishal, Singh Pawan Kumar, Akondy Rama, Ahuja Aman, Kumar Jyothi Geethamohan, Ghosh Munmun, Surapaneni Vineela, Chougale Samruddhi Dhanaji, Ejaz Saima, Mondal Anirban, Chelagla Radhika, Vinod Krishnapriya, Chaudhry Dhruva
Аннотация
BACKGROUND AND OBJECTIVE: Non-invasive ventilation (NIV) and inhaled bronchodilator therapy are foundational in the management of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). However, optimal drug-delivery strategies during NIV remain uncertain. This study compared bronchodilator delivery via a pressurized metered-dose inhaler (pMDI) interface versus standard jet nebulization during NIV.
METHODS: This randomized, open-label trial enrolled adults with hypercapnic AECOPD requiring NIV. Participants were randomized 1:1 to receive ipratropium bromide via pMDI using a modified NIV mask, or via jet nebulizer integrated into the inspiratory limb. Serum ipratropium concentrations at 30 min constituted the primary bioequivalence endpoint, analysed using geometric mean ratios (GMR) and Bayesian posterior probabilities. Secondary outcomes included changes in physiologic parameters, blood gases, ventilatory asynchrony, duration of stay and cost effectiveness.
RESULTS: Forty-four patients were randomized; 41 were included in the intention-to-treat analysis (pMDI n = 20, nebulizer n = 21). At 30 min, geometric mean serum ipratropium levels were higher with pMDI (110.9 pg/mL) versus nebulization (51.6 pg/mL), yielding a GMR of 2.15. Bayesian analysis showed a 95.9% probability that GMR exceeded the non-inferiority threshold (0.80). At 6 h, differences again favoured pMDI (GMR 3.18; p = 0.022; posterior probability 99.8%). Physiologic outcomes, gas exchange, and NIV duration were similar between groups, though ICU stay was shorter in the pMDI arm. No safety concerns or device-related complications were observed. Post hoc cost analysis showed markedly lower therapy cost with pMDI.
CONCLUSIONS: pMDI-based bronchodilator delivery during NIV using a customized interface is feasible, safe, cost-efficient, and achieves higher systemic drug levels than jet nebulization. Larger multicentre trials are warranted to determine clinical impact.
TRIAL REGISTRATION: Clinical Trials Registry of India CTRI/2023/07/054734.
METHODS: This randomized, open-label trial enrolled adults with hypercapnic AECOPD requiring NIV. Participants were randomized 1:1 to receive ipratropium bromide via pMDI using a modified NIV mask, or via jet nebulizer integrated into the inspiratory limb. Serum ipratropium concentrations at 30 min constituted the primary bioequivalence endpoint, analysed using geometric mean ratios (GMR) and Bayesian posterior probabilities. Secondary outcomes included changes in physiologic parameters, blood gases, ventilatory asynchrony, duration of stay and cost effectiveness.
RESULTS: Forty-four patients were randomized; 41 were included in the intention-to-treat analysis (pMDI n = 20, nebulizer n = 21). At 30 min, geometric mean serum ipratropium levels were higher with pMDI (110.9 pg/mL) versus nebulization (51.6 pg/mL), yielding a GMR of 2.15. Bayesian analysis showed a 95.9% probability that GMR exceeded the non-inferiority threshold (0.80). At 6 h, differences again favoured pMDI (GMR 3.18; p = 0.022; posterior probability 99.8%). Physiologic outcomes, gas exchange, and NIV duration were similar between groups, though ICU stay was shorter in the pMDI arm. No safety concerns or device-related complications were observed. Post hoc cost analysis showed markedly lower therapy cost with pMDI.
CONCLUSIONS: pMDI-based bronchodilator delivery during NIV using a customized interface is feasible, safe, cost-efficient, and achieves higher systemic drug levels than jet nebulization. Larger multicentre trials are warranted to determine clinical impact.
TRIAL REGISTRATION: Clinical Trials Registry of India CTRI/2023/07/054734.