Active — Not RecruitingPhase 3

Effect of Perioperative Bronchodilator in COPD Patients Undergoing Lung Cancer Surgery

South Korea204 participantsStarted 2021-04-01

Plain-language 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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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-radio…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in post-bronchodilator FEV1 between baseline and 16 weeks post-surgery

Timeframe: Baseline (T0) and Postoperative 16 to 18 weeks (T3)

Trial details

NCT IDNCT04536675

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-03

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease trials