Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A signed and dated written informed consent prior to study participation.
Outpatient
Subjects 40 years of age or older at Screening (V1).
Male or female subjects.
A female subject is eligible to participate if she is not pregnant (as confirmed by anegative urine human chorionic gonadotrophin [hCG] test), not lactating, and at leastone of the following conditions applies:
Non-reproductive potential as defined in the protocol
Reproductive potential and agrees to follow methods specified in the protocol foravoiding pregnancy in Females of Reproductive Potential (FRP), from 30 days priorto the first dose of study treatment and until after the last dose of studytreatment and completion of the follow-up visit.
An established clinical history of COPD in accordance with the definition by theAmerican Thoracic Society/European Respiratory Society
Current or former cigarette smokers with a history of cigarette smoking of >=10pack-years at Screening [number of pack years = (number of cigarettes per day / 20) xnumber of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes perday for 20 years)]. Previous smokers are defined as those who have stopped smoking forat least 6 months prior to Screening (V1).
A score of >=10 on the COPD Assessment Test (CAT) at Screening (V1).
A post-albuterol/salbutamol FEV1/ forced vital capacity (FVC) ratio of <0.70 and apost-albuterol/salbutamol FEV1 of =<70 percent of predicted normal values at Screening (V1).
Exclusion
Exclusion Criteria:
Women who are pregnant or lactating or are planning on becoming pregnant during thestudy.
Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthmaare eligible if they have a current diagnosis of COPD, which is the primary cause oftheir respiratory symptoms).
Subjects with alpha-1-antitrypsin deficiency as the underlying cause of COPD.
Subjects with active tuberculosis are excluded. Subjects with other respiratorydisorders (e.g. clinically significant: bronchiectasis, sarcoidosis, lung fibrosis,pulmonary hypertension, interstitial lung diseases) are excluded if these conditionsare the primary cause of their respiratory symptoms.
Subjects with lung volume reduction surgery (including procedures such asendobronchial valves) within the 12 months prior to Screening (V1).
Immune suppression (e.g. advanced Human Immunodeficiency Virus (HIV) with high viralload and low CD4 count, Lupus on immunosuppressants that would increase risk ofpneumonia) or other risk factors for pneumonia (e.g. neurological disorders affectingcontrol of the upper airway, such as Parkinson's Disease, Myasthenia Gravis).subjectsat potentially high risk for pneumonia (e.g. very low BMI, severely malnourished, orvery low FEV1) will only be included at the discretion of the investigator.
Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening (V1) and at least 30 days following the last dose oforal/systemic corticosteroids (if applicable).
Other respiratory tract infections that have not resolved at least 7 days prior toScreening (V1).
Chest x-ray reveals evidence of pneumonia or a clinically significant abnormality notbelieved to be due to the presence of COPD, or another condition that would hinder theability to detect an infiltrate on chest x-ray (e.g. significant cardiomegaly, pleuraleffusion or scarring). All subjects will have a chest x-ray at Screening (V1) [orhistorical radiograph or CT scan obtained within 12 months prior to Screening.Subjects who have experienced pneumonia and/or moderate or severe COPD exacerbationwithin 12 months of Screening (V1) must provide a post pneumonia/exacerbation chestx-ray or have a chest x-ray conducted at Screening (V1)].
• For sites in Germany: If a chest x-ray (or CT scan) within 12 months prior toScreening (V1) is not available, approval to conduct a diagnostic chest x-ray willneed to be obtained from the Federal Office for Radiation Protection (BfS).
Subjects with historical or current evidence of clinically significant cardiovascular,neurological, psychiatric, renal, hepatic, immunological, gastrointestinal,urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (includinguncontrolled diabetes or thyroid disease) or haematological abnormalities that areuncontrolled. Significant is defined as any disease that, in the opinion of theInvestigator, would put the safety of the subject at risk through participation, orwhich would affect the efficacy or safety analysis if the disease/conditionexacerbated during the study.
Alanine aminotransferase (ALT) >2x upper limit of normal (ULN); and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and directbilirubin <35 percent).
Current active liver or biliary disease (with the exception of Gilbert's syndrome orasymptomatic gallstones or otherwise stable chronic liver disease per investigatorassessment).
Subjects with any of the following at Screening (V1) are excluded:
Myocardial infarction or unstable angina in the last 6 months
Unstable or life threatening cardiac arrhythmia requiring intervention in thelast 3 months
New York Heart Association Class IV Heart failure
Abnormal and clinically significant 12-Lead electrocardiogram (ECG) finding. Anabnormal and clinically significant finding that would preclude a subject fromentering the trial is defined as a 12-lead tracing that is interpreted as, but notlimited to, any of the following:
Atrial fibrillation with rapid ventricular rate >120 beats per minute;
Sustained or non sustained ventricular tachycardia;
Second degree heart block Mobitz type II and third degree heart block (unlesspacemaker or defibrillator had been inserted).
A history of allergy or hypersensitivity to any corticosteroid,anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein ormagnesium stearate or a medical condition such as narrow-angle glaucoma, prostatichypertrophy or bladder neck obstruction that, in the opinion of the investigator,contraindicates study participation.
Subjects with carcinoma that has not been in complete remission for at least 3 years.Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma andbasal cell carcinoma of the skin would not be excluded based on the 3 year waitingperiod if the subject has been considered cured by treatment.
Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3 liter (L)/min (Oxygen use =<3 L/min flow is not exclusionary)
Subjects who are medically unable to withhold their albuterol/salbutamol for the 4-hour period required prior to spirometry testing at each study visit.
Subjects with a known or suspected history of alcohol or drug abuse within the last 2years.
Subjects at risk of non-compliance, or unable to comply with the study procedures. Anyinfirmity, disability, or geographic location that would limit compliance forscheduled visits.
Subjects with a history of psychiatric disease, intellectual deficiency, poormotivation or other conditions that will limit the validity of informed consent toparticipate in the study.
Study investigators, sub-investigators, study coordinators, employees of aparticipating investigator or study site, or immediate family members of theaforementioned that is involved with this study.
In the opinion of the investigator, any subject who is unable to read and/or would notbe able to complete study related materials.
Use of the below medications within the specified time intervals prior to Screening (V1): 1.Long term continuous antibiotic therapy for >= 30 days 2.Systemic, Oral,parenteral corticosteroids 3.Any other investigational drug
Study Design
Connect with a study center
GSK Investigational Site
Truro, Nova Scotia B2N 1L2
CanadaSite Not Available
GSK Investigational Site
Toronto, Ontario M5G 1N8
CanadaSite Not Available
GSK Investigational Site
St. Charles-Borromee, Quebec J6E 2B4
CanadaSite Not Available
GSK Investigational Site
Geesthacht, Schleswig-Holstein 21502
GermanySite Not Available
GSK Investigational Site
Berlin, 10717
GermanySite Not Available

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