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

NCT04536675 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Samsung Medical Center
Phase	Phase 3
Status	UNKNOWN
Enrolment	204
Start date	2021-04-01
Completion	2024-04

Conditions

• Chronic Obstructive Pulmonary Disease
• Non Small Cell Lung Cancer

Interventions

• Vilanterol and Umeclidinium Bromide
• Placebo

Primary outcomes

• Post-bronchodilator FEV1 at 16 weeks — Postoperative 16 to 18 weeks (T3)
  Post-bronchodilator FEV1 (ml) measured at 16 weeks postoperatively

Countries

South Korea