Chronic Obstructive Pulmonary DiseasePhase 3NCT04536675
Effect of Perioperative Bronchodilator in COPD Patients Undergoing Lung Cancer Surgery
A Phase 3 study testing Vilanterol and Umeclidinium Bromide in people with Chronic Obstructive Pulmonary Disease and Non Small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Non Small Cell Lung Cancer
- What is being tested?
- Vilanterol and Umeclidinium Bromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2021to Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Perioperative Fixed-dose Dual Bronchodilator Therapy on Post-operative Pulmonary Function Among Mild- to -Moderate COPD Patients Undergoing Lung Cancer Surgery
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.
- Being tested
- Vilanterol and Umeclidinium Bromide, Placebo
- Keywords
- Chronic obstructive pulmonary disease, Non-small cell lung cancer, Lobectomy, Dual bronchodilator therapy, Pulmonary function
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vilanterol and Umeclidinium BromideDrug
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.
PlaceboDrug
Perioperative inhaler therapy with placebo once daily using Ellipta device from at least for 2 weeks preoperatively to at least 16 weeks post operatively.
| Study group | Role | What they receive |
|---|---|---|
| VI/UME | Experimental | Anoro (Vilanterol 25mcg/Umeclinidium 62.5mcg) in Ellipta device Inhaled through mouth once daily Receives: Drug: Vilanterol and Umeclidinium Bromide |
| Control | Placebo comparator | Placebo (including lactose monohydrate) in Ellipta device Inhaled through mouth once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in post-bronchodilator FEV1 between baseline and 16 weeks post-surgery
Difference in post-bronchodilator FEV1 (ml) between baseline and 16 weeks post-surgery (T3-T0)
Measured: Baseline (T0) and Postoperative 16 to 18 weeks (T3)
Secondary outcomes (20)
Difference in post-bronchodilator FEV1 between baseline and 16 weeks post-surgery
Difference in post-bronchodilator FEV1 (%pred) between baseline and 16 weeks post-surgery (T3-T0)
Measured: Baseline (T0) and Postoperative 16 to 18 weeks (T3)
Difference between predicted postoperative FEV1 and actual postoperative FEV1 at 16 weeks
Difference between predicted postoperative FEV1 (% predicted; calculated from baseline post-bronchodilator FEV1 [T0] and surgical extent) and actual post-bronchodilator FEV1 (% predicted) at 16 weeks postoperatively (PPO T3 - actual T3)
Measured: Postoperative 16 to 18 weeks (T3) and baseline (T0)
Difference in post-bronchodilator FEV1 between baseline and surgery
Difference in post-bronchodilator FEV1 (ml) between baseline and hospitalization for surgery (T0 - T1)
Measured: Baseline (T0) and before surgery (T1)
Difference in post-bronchodilator FEV1 between baseline and surgery
Difference in post-bronchodilator FEV1 (%pred) between baseline and hospitalization for surgery (T0 - T1)
Measured: Baseline (T0) and before surgery (T1)
Difference in post-bronchodilator FEV1 between hospitalization for surgery and 3 weeks post-surgery
Difference in post-bronchodilator FEV1 (mL) between hospitalization for surgery and 3 weeks post-surgery (T1 - T2)
Measured: Before surgery (T1) and postoperative 2 to 4 weeks (T2)
Difference in post-bronchodilator FEV1 between hospitalization for surgery and 3 weeks post-surgery
Difference in post-bronchodilator FEV1 (% pred) between hospitalization for surgery and 3 weeks post-surgery (T1 - T2)
Measured: Before surgery (T1) and postoperative 2 to 4 weeks (T2)
Post-bronchodilator FEV₁ at 16 weeks post-surgery
Post-bronchodilator FEV1 (mL) at 16 weeks postoperatively (T3)
Measured: Postoperative 16 to 18 weeks (T3)
Post-bronchodilator FEV₁ at 16 weeks post-surgery
Post-bronchodilator FEV1 (% pred) at 16 weeks postoperatively (T3)
Measured: Postoperative 16 to 18 weeks (T3)
Dyspnea and health-related quality of life at postoperative 3 and 16 weeks
mMRC
Measured: 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
CAT
Measured: 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
BFI
Measured: 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
SGRQ-C
Measured: 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
EORTC-QLC C-30
Measured: 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
LC-30
Measured: Postoperative 2 to 4 weeks (T2) and postoperative 16 to 18 weeks (T3)
Exercise tolerance at postoperative 3 and 16 weeks
6-minute walk test distance (meter)
Measured: Postoperative 2 to 4 weeks (T2) and 16 to 18 weeks (T3)
Dyspnea and health-related quality of life at postoperative 3 and 16 weeks
BDI/TDI
Measured: Postoperative 2 to 4 weeks (T2) and postoperative 16 to 18 weeks (T3)
Postoperative pulmonary and cardiac complication
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.
Measured: Within 30 days and 90 days
Length of hospital stay
Length of hospital stay from the admission for lung cancer surgery to discharge or death
Measured: From the admission for lung cancer surgery to discharge or death, whichever comes first
COPD Acute exacerbation
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.
Measured: Between randomization (T0) and postoperative 16 to 18 weeks (T3)
Compliance
The compliance is defined by the percentage of use during the clinical trial: complete adherence (>80%), partial adherence (50-80%), low adherence (<50%).
Measured: Between randomization (T0) and postoperative 16 to 18 weeks (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Apr 2021
- Primary completion3 Apr 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hye Yun Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536675
- Sponsor's protocol ID
- SMC 2020-04-153
- Status last verified
- Jun 2026
- First submitted
- 24 Aug 2020
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19476597Suzuki 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.
PubMed 20872194Bolukbas 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.
PubMed 20970351
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Fixed-dose Dual Bronchodilator Therapy on Post-operative Pulmonary Function Among Mild- to -Moderate COPD Patients Undergoing Lung Cancer Surgery
- ClinicalTrials.gov ID
- NCT04536675
- Acronym / sponsor ID
- SMC 2020-04-153
- Keywords
- Chronic obstructive pulmonary disease, Non-small cell lung cancer, Lobectomy, Dual bronchodilator therapy, Pulmonary function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VI/UME | Experimental | Drug: Vilanterol and Umeclidinium BromideAnoro (Vilanterol 25mcg/Umeclinidium 62.5mcg) in Ellipta device Inhaled through mouth once daily |
| Control | Placebo comparator | Drug: PlaceboPlacebo (including lactose monohydrate) in Ellipta device Inhaled through mouth once daily |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Subjects with dyspnea of 0 or 1 grade measured by modified Medical Research Council (mMRC)
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vilanterol and Umeclidinium BromidePerioperative 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. | Drug | VI/UME |
| PlaceboPerioperative inhaler therapy with placebo once daily using Ellipta device from at least for 2 weeks preoperatively to at least 16 weeks post operatively. | Drug | Control |
Primary outcome
Difference in post-bronchodilator FEV1 between baseline and 16 weeks post-surgery
Time frame: Baseline (T0) and Postoperative 16 to 18 weeks (T3)
Difference in post-bronchodilator FEV1 (ml) between baseline and 16 weeks post-surgery (T3-T0)
20 secondary outcomes
Difference in post-bronchodilator FEV1 between baseline and 16 weeks post-surgery
Time frame: Baseline (T0) and Postoperative 16 to 18 weeks (T3)
Difference between predicted postoperative FEV1 and actual postoperative FEV1 at 16 weeks
Time frame: Postoperative 16 to 18 weeks (T3) and baseline (T0)
Difference in post-bronchodilator FEV1 between baseline and surgery
Time frame: Baseline (T0) and before surgery (T1)
Difference in post-bronchodilator FEV1 between baseline and surgery
Time frame: Baseline (T0) and before surgery (T1)
Difference in post-bronchodilator FEV1 between hospitalization for surgery and 3 weeks post-surgery
Time frame: Before surgery (T1) and postoperative 2 to 4 weeks (T2)
Difference in post-bronchodilator FEV1 between hospitalization for surgery and 3 weeks post-surgery
Time frame: Before surgery (T1) and postoperative 2 to 4 weeks (T2)
Post-bronchodilator FEV₁ at 16 weeks post-surgery
Time frame: Postoperative 16 to 18 weeks (T3)
Post-bronchodilator FEV₁ at 16 weeks post-surgery
Time frame: Postoperative 16 to 18 weeks (T3)
Dyspnea and health-related quality of life at postoperative 3 and 16 weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Postoperative 2 to 4 weeks (T2) and postoperative 16 to 18 weeks (T3)
Exercise tolerance at postoperative 3 and 16 weeks
Time frame: Postoperative 2 to 4 weeks (T2) and 16 to 18 weeks (T3)
Dyspnea and health-related quality of life at postoperative 3 and 16 weeks
Time frame: Postoperative 2 to 4 weeks (T2) and postoperative 16 to 18 weeks (T3)
Postoperative pulmonary and cardiac complication
Time frame: Within 30 days and 90 days
Length of hospital stay
Time frame: From the admission for lung cancer surgery to discharge or death, whichever comes first
COPD Acute exacerbation
Time frame: Between randomization (T0) and postoperative 16 to 18 weeks (T3)
Compliance
Time frame: Between randomization (T0) and postoperative 16 to 18 weeks (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 19476597Kobayashi 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.
- Background: PubMed 20872194Suzuki 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.
- Background: PubMed 20970351Bolukbas 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vilanterol and Umeclidinium Bromide in people with Chronic Obstructive Pulmonary Disease and Non Small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in post-bronchodilator FEV1 between baseline and 16 weeks post-surgery (time frame: Baseline (T0) and Postoperative 16 to 18 weeks (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04536675, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.