NCT04536675

Effect of Perioperative Bronchodilator in COPD Patients Undergoing Lung Cancer Surgery

Effect of Perioperative Fixed-dose Dual Bronchodilator Therapy on Post-operative Pulmonary Function Among Mild- to -Moderate COPD Patients Undergoing Lung Cancer Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind randomized controlled trial evaluating the effect of perioperative dual bronchodilator therapy on post-operative pulmonary function and health-related quality of life (QoL) in mild-to-moderate less symptomatic COPD patients undergoing lung cancer surgery. Investigators hypothesized that dual bronchodilator, as compared with placebo, would prevent reduction of pulmonary function after surgical resection and improve postoperative health related QoL.

Conditions

• Chronic Obstructive Pulmonary Disease
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Vilanterol and Umeclidinium Bromide	Perioperative inhaler therapy with VI/UME (Vilanterol 25mcg/Umeclidinium 62.5mcg) once daily using Ellipta device from at least for 2 weeks preoperatively to at least 16 weeks post operatively.
DRUG	Placebo	Perioperative inhaler therapy with placebo once daily using Ellipta device from at least for 2 weeks preoperatively to at least 16 weeks post operatively.

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-11-01
• Completion: 2024-04-01
• First posted: 2020-09-03
• Last updated: 2021-04-02

Locations

1 site across 1 country: South Korea