Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Lung Neoplasms

Lung Diseases

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Anticonvulsants

All Drugs and Chemicals

Respiratory System Agents

Bromides

Bronchodilator Agents

Anoro (Vilanterol 25mcg/Umeclinidium 62.5mcg) in Ellipta device Inhaled through mouth once daily

Placebo (including lactose monohydrate) in Ellipta device Inhaled through mouth once daily

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.

Vilanterol and Umeclidinium Bromide

Perioperative inhaler therapy with placebo once daily using Ellipta device from at least for 2 weeks preoperatively to at least 16 weeks post operatively.

Placebo

Hye Yun Park, MD PhD

Hye Yun Park, MD, PhD

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.

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

Post-bronchodilator FEV1 (ml) measured at 16 weeks postoperatively

Difference of predicted postoperative FEV1 (% predicted; calculated from baseline post-bronchodilator FEV1 \[T0\] and surgical extent) and actual post-bronchodilator FEV1 (% predicted) at 4 months postoperatively (PPO T3 - actual T3)

Difference of post-bronchodilator FEV1 (ml) at baseline and post-bronchodilator FEV1 (ml) before surgery (T0 - T1)

Difference of post-bronchodilator FEV1 (ml) before surgery and post-bronchodilator FEV1 (ml) at 3 weeks postoperatively (T1 - T2)

Postoperative pulmonary complications (PPC) occurring within the first 30 postoperative days is defined as any of the following conditions: 1) atelectasis requiring bronchoscopic toileting; 2) pneumonia (at least three among leukocytosis, pulmonary infiltrate or consolidation, fever \[\>38℃\], culture-positive, or use of antibiotics); 3) acute lung injury or acute respiratory distress syndrome (rate of arterial oxygen partial pressure to fractional inspired oxygen \[PaO2/FiO2\] \<300 and bilateral infiltrate seen on chest radiograph without evidence of congestive heart failure or volume overload), or 4) acute exacerbation of chronic obstructive pulmonary disease. Postoperative cardiac complications (PCC) was defined as acute myocardial infarction, ventricular tachycardia/fibrillation, primary cardiac arrest, complete heart block, any cardiac-related death, or atrial arrhythmia associated with the use of anti-arrhythmic drugs or anti-coagulants.

Length of hospital stay from the admission for lung cancer surgery to discharge or death

Moderate acute exacerbation is defined as a clinic visit and severe acute exacerbations is defined as a hospitalization or an emergency room visit owing to one or more of the following worsening of dyspnea, increased sputum volume and purulent sputum requiring antibiotics and/ or oral corticosteroids.

The compliance is defined by the percentage of use during the clinical trial: complete adherence (\>80%), partial adherence (50-80%), low adherence (\<50%).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Perioperative Bronchodilator in COPD Patients Undergoing Lung Cancer Surgery	NCT04536675	Chronic Obstruc... Non Small Cell ...	Vilanterol and ... Placebo	40 Years -	Samsung Medical Center
Effect of Perioperative Bronchodilator in COPD Patients Undergoing Lung Cancer Surgery	NCT04536675	Chronic Obstruc... Non Small Cell ...	Vilanterol and ... Placebo	40 Years -	Samsung Medical Center
Effect of Perioperative Bronchodilator in COPD Patients Undergoing Lung Cancer Surgery	NCT04536675	Chronic Obstruc... Non Small Cell ...	Vilanterol and ... Placebo	40 Years -	Samsung Medical Center

Spots Global Cancer Trial Database for vilanterol and umeclidinium bromide