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
In brief
In 314 adults, nebulized triple therapy matched inhaler lung-function gains
After 12 weeks, nebulized glycopyrronium, formoterol and budesonide was no worse than the same triple therapy by metered-dose inhaler for trough lung function in people with COPD. Side effects were comparable, and the nebulized group had a greater improvement in breathlessness scores, but the trial does not establish whether that difference matters to patients over longer-term use.
- Journal
- Respiratory medicine (Q1)
- Published
- 16 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Rahul Kodgule, Sunil Jagdale, Wen Wu, Rajkumar Nikalje, Maheshkumar Vaghani, Mohammad Hafiz, et al.
- PMID
- 42887614
- DOI
- 10.1016/j.rmed.2026.109220
Why clinicians should know about it
- Picked for Pulmonary and Respiratory Medicine (top studies of the week, 25 October 2026): Nebulized triple therapy non‑inferior to MDI in COPD
Abstract
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 one second (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-hour 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).
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.