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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
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.
Perioperative inhaler therapy with placebo once daily using Ellipta device from at least for 2 weeks preoperatively to at least 16 weeks post operatively.
Samsung Medical Center
Seoul, South Korea
RECRUITINGPost-bronchodilator FEV1 at 16 weeks
Post-bronchodilator FEV1 (ml) measured at 16 weeks postoperatively
Time frame: Postoperative 16 to 18 weeks (T3)
Difference of predicted postoperative FEV1 and actual postoperative FEV1 at 16 weeks
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)
Time frame: Postoperative 16 to 18 weeks (T3) and baseline (T0)
Difference of post-bronchodilator FEV1 between baseline and surgery
Difference of post-bronchodilator FEV1 (ml) at baseline and post-bronchodilator FEV1 (ml) before surgery (T0 - T1)
Time frame: Baseline (T0) and before surgery (T1)
Difference of post-bronchodilator FEV1 before surgery and at 3 weeks
Difference of post-bronchodilator FEV1 (ml) before surgery and post-bronchodilator FEV1 (ml) at 3 weeks postoperatively (T1 - T2)
Time frame: Before surgery (T1) and postoperative 2 to 4 weeks (T2)
Dyspnea and health-related quality of life at postoperative 3 and 16 weeks
mMRC
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
CAT
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
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BFI
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
SGRQ-C
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
EORTC-QLC C-30
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
LC-30
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
BDI/TDI
Time frame: 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)
Time frame: Postoperative 2 to 4 weeks (T2) and 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.
Time frame: 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
Time frame: 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.
Time frame: 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%).
Time frame: Between randomization (T0) and postoperative 16 to 18 weeks (T3)