Respiratory medicine · 2026
Efficacy and safety of novel nebulized combination of glycopyrronium, formoterol and budesonide in comparison with metered dose inhaler of glycopyrronium, formoterol and budesonide in COPD - A randomized, double-blind, double-dummy clinical trial.
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Kodgule Rahul, Jagdale Sunil, Wu Wen, Nikalje Rajkumar, Vaghani Maheshkumar, Hafiz Mohammad, Balki Akash, Khator Sanjay, Jain Manish Kumar, Pendse Amol, Rangwala Shabbir, Tandon Monika
Аннотация
BACKGROUND: Many patients with chronic obstructive pulmonary disease (COPD) are unable to use metered dose inhaler (MDI) or dry powder inhaler effectively and require treatment with nebulized medication. No triple combination is available in nebulized form.
METHODS: In this randomized, double-blind study, 314 patients with COPD received either Glycopyrronium 25 μg/Formoterol Fumarate 20 μg/Budesonide 500 μg (GB/FF/BUD Neb) by nebulization twice daily or Glycopyrronium 7.2 μg, Formoterol Fumarate 5 μg, Budesonide 160 μg MDI (GB/FF/BUD MDI) 2 Puffs twice daily for 12 weeks. The primary endpoint was change from baseline in trough forced expiratory volume in 1 s (FEV1) at week 12.
RESULTS: At week 12, GB/FF/BUD Neb was non-inferior (NI) to GB/FF/BUD MDI in change from baseline in trough FEV1 [LS mean (SE) difference -0.00 L (95% CI, -0.04 to 0.04); p < 0.001 for NI with NI margin -0.08 L). At week 12, the between group difference was 0.04 L (95% CI: -0.00 to 0.09; p = 0.070) in 2-h post-dose FEV1 and -0.24 (95% CI: -0.42 to -0.07; p = 0.007) in the modified Medical Research Council (mMRC) dyspnoea score. There was no difference between treatments in the rescue medication use and change from baseline in trough forced vital capacity. No serious adverse event or death was reported. Overall, adverse events were comparable between the two groups.
CONCLUSION: GB/FF/BUD Neb was non-inferior to GB/FF/BUD MDI in improving lung function evaluated by trough FEV1 in patients with COPD. GB/FF/BUD Neb was found to be safe and well tolerated.
CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2024/10/075606 (Clinical Trial Registry - India).
METHODS: In this randomized, double-blind study, 314 patients with COPD received either Glycopyrronium 25 μg/Formoterol Fumarate 20 μg/Budesonide 500 μg (GB/FF/BUD Neb) by nebulization twice daily or Glycopyrronium 7.2 μg, Formoterol Fumarate 5 μg, Budesonide 160 μg MDI (GB/FF/BUD MDI) 2 Puffs twice daily for 12 weeks. The primary endpoint was change from baseline in trough forced expiratory volume in 1 s (FEV1) at week 12.
RESULTS: At week 12, GB/FF/BUD Neb was non-inferior (NI) to GB/FF/BUD MDI in change from baseline in trough FEV1 [LS mean (SE) difference -0.00 L (95% CI, -0.04 to 0.04); p < 0.001 for NI with NI margin -0.08 L). At week 12, the between group difference was 0.04 L (95% CI: -0.00 to 0.09; p = 0.070) in 2-h post-dose FEV1 and -0.24 (95% CI: -0.42 to -0.07; p = 0.007) in the modified Medical Research Council (mMRC) dyspnoea score. There was no difference between treatments in the rescue medication use and change from baseline in trough forced vital capacity. No serious adverse event or death was reported. Overall, adverse events were comparable between the two groups.
CONCLUSION: GB/FF/BUD Neb was non-inferior to GB/FF/BUD MDI in improving lung function evaluated by trough FEV1 in patients with COPD. GB/FF/BUD Neb was found to be safe and well tolerated.
CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2024/10/075606 (Clinical Trial Registry - India).