A 24 Week Efficacy Study of Inhaled Umeclidinium (UMEC) in Patients of Chronic Obstructive Pulmonary Disease (COPD) Using a Novel Dry Powder Inhaler (NDPI)

Inclusion Criteria

• Type of subject: outpatient, Asian ancestry.
• Informed Consent: A signed and dated written informed consent prior to study participation.
• Age: 40 years of age or older at Screening (Visit 1).
• Gender: Male or female subjects are eligible to participate in the study. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, >45 years, in the absence of hormone replacement therapy. However, in questionable cases, post-menopause status may be confirmed by analysis of a blood sample with follicle-stimulating hormone (FSH) >40 million international units per milliliter (MIU/ml) and estradiol = 10 pack-years [Number of pack years = (number of cigarettes per day /20) x number of years smoked (e.g. 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years both equal 10 pack years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history. COPD patients who only use a pipe and/or cigar are not eligible.
• Severity of Disease: A pre and post-salbutamol/albuterol FEV1/FVC ratio of =2 on the Modified Medical Research Council Dyspnoea Scale (mMRC) at Screening (Visit 1)

Exclusion Criteria

• Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
• Asthma: A current diagnosis of asthma.
• Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis) and lung cancer are absolute exclusionary conditions. A subject, who in the opinion of the investigator has any other significant respiratory conditions in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis or interstitial lung disease.
• Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for 100bpm).Atrial fibrillation with rapid ventricular response (rate >120bpm). Atrial flutter with rapid ventricular response (rate >120bpm). Ventricular tachycardias (non sustained, sustained, polymorphic, or monomorphic). Ventricular flutter. Ventricular fibrillation. Torsades de Pointes. Evidence of Mobitz type II second degree or third degree atrioventricular (AV) block. AV dissociation. Trifascicular Block. For subjects with QRS duration 120: QTc(F) ≥480msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave). Myocardial infarction (acute or recent) * Note: Evidence of an old (resolved) myocardial infarction is not exclusionary. The study investigator will determine the medical significance of any ECG abnormalities not listed above.
• Screening Labs: Significantly abnormal findings from clinical chemistry and haematology tests at Visit 1.
• Medications Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
• Medications Prior to Screening: Use of the following medications according to the following defined time intervals prior to Visit 1 is presented as Medication with Time Interval Prior to Visit 1: Depot corticosteroids (12 weeks); Systemic, oral, parenteral (intra-articular) corticosteroids (4 weeks); Antibiotics (for lower re