Effect of Perioperative Bronchodilator in COPD Patients Undergoing Lung Cancer Surgery

Inclusion Criteria:

• Subjects of men or female over 40 years of age who are scheduled for curativepulmonary lobectomy due to confirmation (or high suspicion) of non-small cell lungcancer (NSCLC)
• Subjects waiting at least 14 days for scheduled pulmonary lobectomy
• Subjects who are newly diagnosed with COPD* or who have not used any bronchodilatorswithin 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 becomingpregnant during the clinical trial, or of child bearing potential not usingcontraception methods
• COPD treatment/acute exacerbation: subjects who have been treated with COPD within thepast 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, oralcorticosteroids, emergency treatment, or hospitalization due to at least one symptomfrom increased breathlessness, sputum volume, or sputum purulence)
• Other pulmonary diseases: subjects who are physician-diagnosed with asthma orIdiopathic Pulmonary Fibrosis (IPF)
• Lung cancer treatment: subjects who have been received neo-adjuvant treatment for lungcancer (chemotherapy, radiotherapy, or concurrent chemo-radiotherapy)
• Other diseases/abnormalities: subjects diagnosed with historical or current evidenceof clinically significant cardiovascular, neurological, psychiatric, renal, hepatic,immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin,sensory, endocrine (including uncontrolled diabetes or thyroid disease) orhematological abnormalities including medical condition corresponding to 'warnings andprecautions' (such as coronary artery disease, acute myocardial infarction, cardiacarrhythmia, hypertension, convulsive disorders, thyrotoxicosis, hypokalemia, diabetes,narrow-angle glaucoma, urinary retention, prostatic hyperplasia, bladder-neckobstruction etc.) that are uncontrolled and/or with cancer within 5 years (Significantis defined as any disease that, in the opinion of the Investigator, would put thesafety of the subject at risk through participation, or which would affect theefficacy or safety analysis if the disease/condition exacerbated during the study.)
• Abnormal and clinically significant 12-Lead Eletrocardiogram (ECG): subjects withabnormal and clinically significant ECG findings (Significant is defined as anydisease that, in the opinion of the Investigator, would put the safety of the subjectat risk through participation, or which would affect the efficacy or safety analysisif the disease/condition exacerbated during the study.)
• Contraindications: subjects with a history of allergy or hypersensitivity to anyLong-Acting Muscarinic Antagonist (LAMA), Long-Acting Beta-Agonist (LABA),lactose/milk protein, stearic magnesium, with generic problems including galactoseintolerance, Lapp lactose deficiency, or glucose-galactose malabsorption, or withcontraindication of inhaled anticholinergic-containing drugs
• Mobility: subjects who are not able to walk independently without mobility assistanceor other people