- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04536675
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
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Hye Yun Park, MD PhD
- Phone Number: +82-2-3410-3429
- Email: hyeyunpark@skku.edu
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Samsung Medical Center
-
Contact:
- Hye Yun Park, MD, PhD
- Email: hyeyunpark@skku.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VI/UME
Anoro (Vilanterol 25mcg/Umeclinidium 62.5mcg) in Ellipta device Inhaled through mouth once daily
|
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.
|
Placebo Comparator: Control
Placebo (including lactose monohydrate) in Ellipta device Inhaled through mouth once daily
|
Perioperative inhaler therapy with placebo once daily using Ellipta device from at least for 2 weeks preoperatively to at least 16 weeks post operatively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-bronchodilator FEV1 at 16 weeks
Time Frame: Postoperative 16 to 18 weeks (T3)
|
Post-bronchodilator FEV1 (ml) measured at 16 weeks postoperatively
|
Postoperative 16 to 18 weeks (T3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of predicted postoperative FEV1 and actual postoperative FEV1 at 16 weeks
Time Frame: Postoperative 16 to 18 weeks (T3) and baseline (T0)
|
Difference of predicted postoperative FEV1 (% predicted; calculated from baseline post-bronchodilator FEV1 [T0] and surgical extent) and actual post-bronchodilator FEV1 (% predicted) at 4 months postoperatively (PPO T3 - actual T3)
|
Postoperative 16 to 18 weeks (T3) and baseline (T0)
|
Difference of post-bronchodilator FEV1 between baseline and surgery
Time Frame: Baseline (T0) and before surgery (T1)
|
Difference of post-bronchodilator FEV1 (ml) at baseline and post-bronchodilator FEV1 (ml) before surgery (T0 - T1)
|
Baseline (T0) and before surgery (T1)
|
Difference of post-bronchodilator FEV1 before surgery and at 3 weeks
Time Frame: Before surgery (T1) and postoperative 2 to 4 weeks (T2)
|
Difference of post-bronchodilator FEV1 (ml) before surgery and post-bronchodilator FEV1 (ml) at 3 weeks postoperatively (T1 - T2)
|
Before surgery (T1) and postoperative 2 to 4 weeks (T2)
|
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)
|
mMRC
|
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)
|
CAT
|
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)
|
BFI
|
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)
|
SGRQ-C
|
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)
|
EORTC-QLC C-30
|
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)
|
LC-30
|
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)
|
BDI/TDI
|
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)
|
6-minute walk test distance (meter)
|
Postoperative 2 to 4 weeks (T2) and 16 to 18 weeks (T3)
|
Postoperative pulmonary and cardiac complication
Time Frame: Within 30 days and 90 days
|
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.
|
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
|
Length of hospital stay from the admission for lung cancer surgery to discharge or death
|
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)
|
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.
|
Between randomization (T0) and postoperative 16 to 18 weeks (T3)
|
Compliance
Time Frame: Between randomization (T0) and postoperative 16 to 18 weeks (T3)
|
The compliance is defined by the percentage of use during the clinical trial: complete adherence (>80%), partial adherence (50-80%), low adherence (<50%).
|
Between randomization (T0) and postoperative 16 to 18 weeks (T3)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMC 2020-04-153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on Vilanterol and Umeclidinium Bromide
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited States, Germany, Japan, Ukraine, Estonia, Belgium, France, Sweden, Netherlands, Philippines, Denmark, Hungary, Norway, Slovakia
-
Chiesi Farmaceutici S.p.A.CompletedChronic Obstructive Pulmonary Disease | AsthmaUnited Kingdom
-
Luis Puente MaestuRecruiting
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUkraine, Slovakia
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveGermany, Estonia
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveGermany, United States, South Africa
-
Novartis PharmaceuticalsCompletedChronic Obstructive Pulmonary DiseaseUnited States
-
Queen's UniversityGlaxoSmithKlineCompleted
-
Gary L. PierceCompleted
-
Novartis PharmaceuticalsCompletedChronic Obstructive Pulmonary DiseaseUnited States