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

Samsung Medical Center1 site in 1 country204 target enrollmentApril 1, 2021

ConditionsChronic Obstructive Pulmonary Disease Non Small Cell Lung Cancer

InterventionsVilanterol and Umeclidinium Bromide Placebo

DrugsVilanterol and Umeclidinium Bromide Placebo

Overview

Phase: Phase 3
Intervention: Vilanterol and Umeclidinium Bromide
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Samsung Medical Center
Enrollment: 204
Locations: 1
Primary Endpoint: Post-bronchodilator FEV1 at 16 weeks
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 1, 2021

End Date

April 2024

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

Hye Yun Park

Associate Professor

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

•Subjects of men or female over 40 years of age who are scheduled for curative pulmonary lobectomy due to confirmation (or high suspicion) of non-small cell lung cancer (NSCLC)
•Subjects waiting at least 14 days for scheduled pulmonary lobectomy
•Subjects who are newly diagnosed with COPD\* or who have not used any bronchodilators within the past 3 months, even if they have previously been diagnosed with COPD
•COPD : Post-bronchodilator (Post-BD) FEV1/FVC \<0.7 and Post-BD FEV1 ≥70 %predicted (%pred)
•Subjects with dyspnea of 0 or 1 grade measured by modified Medical Research Council (mMRC)

Exclusion Criteria

•Pregnancy: subjects of women who are pregnant, lactating, planning on becoming pregnant during the clinical trial, or of child bearing potential not using contraception methods
•COPD treatment/acute exacerbation: subjects who have been treated with COPD within the past 3 months or have experienced acute exacerbation of COPD within the past 1 month (Acute exacerbation of COPD is defined as the cases requiring antibiotics, oral corticosteroids, emergency treatment, or hospitalization due to at least one symptom from increased breathlessness, sputum volume, or sputum purulence)
•Other pulmonary diseases: subjects who are physician-diagnosed with asthma or Idiopathic Pulmonary Fibrosis (IPF)
•Lung cancer treatment: subjects who have been received neo-adjuvant treatment for lung cancer (chemotherapy, radiotherapy, or concurrent chemo-radiotherapy)
•Other diseases/abnormalities: subjects diagnosed with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities including medical condition corresponding to 'warnings and precautions' (such as coronary artery disease, acute myocardial infarction, cardiac arrhythmia, hypertension, convulsive disorders, thyrotoxicosis, hypokalemia, diabetes, narrow-angle glaucoma, urinary retention, prostatic hyperplasia, bladder-neck obstruction etc.) that are uncontrolled and/or with cancer within 5 years (Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.)
•Abnormal and clinically significant 12-Lead Eletrocardiogram (ECG): subjects with abnormal and clinically significant ECG findings (Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.)
•Contraindications: subjects with a history of allergy or hypersensitivity to any Long-Acting Muscarinic Antagonist (LAMA), Long-Acting Beta-Agonist (LABA), lactose/milk protein, stearic magnesium, with generic problems including galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption, or with contraindication of inhaled anticholinergic-containing drugs
•Mobility: subjects who are not able to walk independently without mobility assistance or other people

Arms & Interventions

VI/UME

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

Intervention: Vilanterol and Umeclidinium Bromide

Control

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

Intervention: Placebo

Outcomes

Primary Outcomes

Post-bronchodilator FEV1 at 16 weeks

Time Frame: Postoperative 16 to 18 weeks (T3)

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

Secondary Outcomes

Difference of predicted postoperative FEV1 and actual postoperative FEV1 at 16 weeks(Postoperative 16 to 18 weeks (T3) and baseline (T0))
Difference of post-bronchodilator FEV1 between baseline and surgery(Baseline (T0) and before surgery (T1))
Difference of post-bronchodilator FEV1 before surgery and at 3 weeks(Before surgery (T1) and postoperative 2 to 4 weeks (T2))
Dyspnea and health-related quality of life at postoperative 3 and 16 weeks(Postoperative 2 to 4 weeks (T2) and postoperative 16 to 18 weeks (T3))
Exercise tolerance at postoperative 3 and 16 weeks(Postoperative 2 to 4 weeks (T2) and 16 to 18 weeks (T3))
Postoperative pulmonary and cardiac complication(Within 30 days and 90 days)
Length of hospital stay(From the admission for lung cancer surgery to discharge or death, whichever comes first)
COPD Acute exacerbation(Between randomization (T0) and postoperative 16 to 18 weeks (T3))
Compliance(Between randomization (T0) and postoperative 16 to 18 weeks (T3))