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

Sponsors

Lead Sponsor: Samsung Medical Center

Source Samsung Medical Center
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.

Overall Status Not yet recruiting
Start Date September 2020
Completion Date April 2024
Primary Completion Date November 2023
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Post-bronchodilator FEV1 at 16 weeks Postoperative 16 to 18 weeks (T3)
Secondary Outcome
Measure Time Frame
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)
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)
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)
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)
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)
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)
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)
Enrollment 204
Condition
Intervention

Intervention Type: Drug

Intervention Name: Vilanterol and Umeclidinium Bromide

Description: 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.

Arm Group Label: VI/UME

Intervention Type: Drug

Intervention Name: Placebo

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

Arm Group Label: Control

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

Gender: All

Minimum Age: 40 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Hye Yun Park, MD PhD

Phone: +82-2-3410-3429

Email: [email protected]

Verification Date

August 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Samsung Medical Center

Investigator Full Name: Hye Yun Park

Investigator Title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: VI/UME

Type: Experimental

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

Label: Control

Type: Placebo Comparator

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

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov