Budesonide/glycopyrronium/formoterol fumarate co-suspension metered dose inhaler relieves cough after lobectomy: a randomized controlled study.

Abstract

Background: Cough after pulmonary resection (CAP) has emerged as a prevalent complication. However, existing treatment protocols for CAP lack standardization. The components of the budesonide/glycopyrronium/formoterol fumarate co-suspension metered dose inhaler (BGF MDI) have been consistently documented for their effectiveness in cough management. Consequently, we initiated this clinical trial to evaluate the efficacy and safety of BGF MDI in mitigating CAP.

Methods: Enrolled participants exhibited no pre-existing cough before undergoing lobectomy. The patients were randomly assigned in a 1:1 ratio to either the BGF MDI group or the Control group. The BGF MDI group received BGF MDI for 14 consecutive days postoperatively; each participant in both groups underwent continuous follow-up for 60 days. Cough severity, duration, and cough-related quality of life were evaluated. The primary endpoints were focused on the occurrence of obvious CAP lasting ≥14 days.

Results: Finally, 51 patients in the BGF MDI group and 52 patients in the Control group were included in the analysis after accounting for dropout. The BGF MDI group demonstrated a reduction in the incidence of obvious CAP lasting ≥14 days (13.7% vs. 40.4%). The cough-related quality of life for the BGF MDI group on the 14th and 30th days after surgery was higher. Three participants in the BGF MDI group reported palpitations, with no other complications noted.

Conclusions: BGF MDI has shown efficacy and safety in reducing CAP severity and duration. Using BGF MDI after lobectomy helps to alleviate cough symptoms and speed up postoperative recovery.

Trial registration: Clinicaltrials.gov. Clinical Trial Registry Number: NCT05472350.