Evaluating the Control of COPD Symptoms in Patients Treated With Tiotropium Bromide 18mcg Once Daily Alone, ADOAIR 50/250mcg Twice Daily Alone or ADOAIR 50/250mcg Plus Tiotropium Bromide 18mcg

Inclusion Criteria

• Male or female aged 40 - 80 years inclusive
• Has an established clinical history of COPD (defined as per the GOLD definition)
• The subject achieves a grade of ≥1 on mMRC at Visit 1
• A signed and dated written informed consent is obtained from the subject prior to study participation
• The subject has a post-bronchodilator FEV1 of ≥ 30% to ≤ 80% of predicted normal
• The subject has a post-bronchodilator FEV1 / FVC ratio 10 pack-years Ex-smokers are required to have stopped smoking for at least 6 months prior to visit 1. Ex-smokers who stopped smoking less than 6 months ago will be defined as current smokers.
• QTc 35% direct bilirubin) 10. A female is eligible to enter this study if she is: i) of non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal), or ii) of child-bearing potential, but has a negative urinary pregnancy test at screening and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study iii) not a nursing mother

Exclusion Criteria

• Has a predominant asthma (comorbid asthma is not an exclusion criteria)
• Has a medical diagnosis of narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction that in the opinion of the investigator should prevent them from entering the study Note: As with other anticholinergic drugs, subjects with narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction should only be entered into the study at the Investigator's discretion
• Has known respiratory disorders other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis)
• Has undergone lung surgery e.g., lung transplant and/or lung volume reduction
• Had a chest X-ray indicating diagnosis other than COPD that might interfere with the study (chest X-ray to be taken at Visit 1, if subject has not had one and/or CT image taken within 3 months of Visit 1)
• Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as ≥ 12 hours oxygen use per day)
• Has plan to start or to change the pulmonary rehabilitation program during the study period
• Requires regular treatment with oral, parenteral, or depot corticosteroids
• Has serious, uncontrolled disease likely to interfere with the study (e.g. Left Ventricular failure, anaemia, renal or hepatic disease or serious psychological disorders)
• Received any other investigational drugs within 4 weeks (or 5 half lives) prior to Visit 1
• Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse
• Has a known or suspected hypersensitivity to β2-agonists, steroids, anticholinergic treatments or any components of the formulations
• Has previously been enrolled to this study and investigational drugs has been administered
• Is not eligible to participate this study in the opinion of the investigator/subinvestigator

The investigator must refer to the following document(s) for detailed information regarding warnings, precautions, contraindications, adverse events, and other significant data pertaining to the investigational product(s) being used in this study:

• ADOAIR DISKUS package insert
• Tiotropium/ HandiHaler package insert
• Salbutamol package insert