Effect of Perioperative Bronchodilator in COPD Patients Undergoing Lung Cancer Surgery

NCT04536675 | Unknown Phase 3 DMC

• 1 other identifier: SMC 2020-04-153
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Non Small Cell Lung Cancer

Keywords

Chronic obstructive pulmonary disease; Non-small cell lung cancer; Lobectomy; Dual bronchodilator therapy; Pulmonary function

Outcome Measures

Primary Outcomes (1)

• Post-bronchodilator FEV1 at 16 weeks

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

  Postoperative 16 to 18 weeks (T3)

Secondary Outcomes (15)

• 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)

Study Arms (2)

VI/UME

EXPERIMENTAL

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

Drug: Vilanterol and Umeclidinium Bromide

Control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Vilanterol and Umeclidinium Bromide DRUG

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.

VI/UME

Placebo DRUG

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

Control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (3)

• Kobayashi S, Suzuki S, Niikawa H, Sugawara T, Yanai M. Preoperative use of inhaled tiotropium in lung cancer patients with untreated COPD. Respirology. 2009 Jul;14(5):675-9. doi: 10.1111/j.1440-1843.2009.01543.x. Epub 2009 May 19.

  PMID: 19476597 BACKGROUND

• Suzuki H, Sekine Y, Yoshida S, Suzuki M, Shibuya K, Takiguchi Y, Tatsumi K, Yoshino I. Efficacy of perioperative administration of long-acting bronchodilator on postoperative pulmonary function and quality of life in lung cancer patients with chronic obstructive pulmonary disease. Preliminary results of a randomized control study. Surg Today. 2010 Oct;40(10):923-30. doi: 10.1007/s00595-009-4196-1. Epub 2010 Sep 25.

  PMID: 20872194 BACKGROUND

• Bolukbas S, Eberlein M, Eckhoff J, Schirren J. Short-term effects of inhalative tiotropium/formoterol/budenoside versus tiotropium/formoterol in patients with newly diagnosed chronic obstructive pulmonary disease requiring surgery for lung cancer: a prospective randomized trial. Eur J Cardiothorac Surg. 2011 Jun;39(6):995-1000. doi: 10.1016/j.ejcts.2010.09.025. Epub 2010 Oct 22.

  PMID: 20970351 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Carcinoma, Non-Small-Cell Lung

Interventions

vilanterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Hye Yun Park, MD PhD

CONTACT

+82-2-3410-3429; hyeyunpark@skku.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 3, 2020
• Study Start: April 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: April 1, 2024
• Last Updated: April 2, 2021

Record last verified: 2021-04

Locations

KR (1)