Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Type of subject: Outpatient.
Informed Consent: A signed and dated written informed consent prior to studyparticipation.
Age: 40 years of age or older at Visit 1.
Gender: Male or female subjects.
Diagnosis: An established clinical history of COPD in accordance with the definitionby the American Thoracic Society/European Respiratory Society [Celli, 2004]
Smoking History: Current or former cigarette smokers with a history of cigarettesmoking of ≥ 10 pack-years
Severity of Disease: A post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and apost-albuterol/salbutamol FEV1 of >35% and <70% of predicted normal
Dyspnea: A score of ≥2 on the Modified Medical Research Council Dyspnea Scale (mMRC)at Visit 1
Resting Lung Volumes: A resting FRC of ≥120% of predicted normal FRC at Visit 1.
Exclusion
Exclusion Criteria:
Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnantduring the study.
Asthma: A current diagnosis of asthma.
Other Respiratory Disorders: Known respiratory disorders other than COPD including butnot limited to alpha-1 antitrypsin deficiency, active tuberculosis, bronchiectasis,sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease.Allergic rhinitis is not exclusionary.
Other Diseases/Abnormalities: Subjects with historical or current evidence ofclinically significant cardiovascular, neurological, psychiatric, renal, hepatic,immunological, endocrine (including uncontrolled diabetes or thyroid disease) orhaematological abnormalities that are uncontrolled and/or a previous history of cancerin remission for < 5 years prior to Visit 1 (localized carcinoma of the skin that hasbeen resected for cure is not exclusionary). Significant is defined as any diseasethat, in the opinion of the investigator, would put the safety of the subject at riskthrough participation, or which would affect the efficacy or safety analysis if thedisease/condition exacerbated during the study. Any physical or mental abnormalitywhich would affect the patient carrying out exercise tests including peripheralvascular disease should be excluded at the investigators discretion.
Chest X-Ray: A chest X-ray or computed tomography (CT) scan that reveals evidence ofclinically significant abnormalities not believed to be due to the presence of COPD. Achest X-ray must be taken at Visit 1 if a chest X-ray or CT scan is not availablewithin 6 months prior to Visit 1. For subjects in Germany, if a chest X-ray (or CTscan) is not available in the 6 months prior to Visit 1 the subject will not beeligible for the study.
Contraindications: A history of allergy or hypersensitivity to anyanticholinergic/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 study physiciancontraindicates study participation or use of an inhaled anticholinergic.
Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit
Lung Resection: Subjects with lung volume reduction surgery within the 12 months priorto Screening (Visit 1).
12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted atVisit 1, including the presence of a paced rhythm on a 12-lead electrocardiogram (ECG)which causes the underlying rhythm and ECG to be obscured. Investigators will beprovided with ECG reviews conducted by a centralized independent cardiologist toassist in evaluation of subject eligibility.
Screening Labs: Significantly abnormal finding from clinical chemistry and hematologytests at Visit 1.
Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hourperiod required prior to spirometry testing at each study visit.
Medications prior to Screening, including depot,oral corticosteroids, combinations ofLABA/ICS, LABA, PDE4 inhibitors.
Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribedfor greater than 12 hours a day. As-needed oxygen use (i.e., <12 hours per day) is notexclusionary.
Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use)of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy
Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonaryrehabilitation program within 4 weeks prior to Visit 1. Subjects who are in themaintenance phase of a pulmonary rehabilitation program are not excluded.
Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2years prior to Visit 1.
Affiliation with Investigator Site: Is an investigator, sub-investigator, studycoordinator, employee of a participating investigator or study site, or immediatefamily member of the aforementioned that is involved in this study
Study Design
Study Description
Connect with a study center
GSK Investigational Site
Plovdiv, 4000
BulgariaSite Not Available
GSK Investigational Site
Sofia, 1000
BulgariaSite Not Available
GSK Investigational Site
Tallinn, 13619
EstoniaSite Not Available
GSK Investigational Site
Tartu, 51014
EstoniaSite Not Available
GSK Investigational Site
Gelnhausen, Hessen 63571
GermanySite Not Available
GSK Investigational Site
Wiesbaden, Hessen 65187
GermanySite Not Available
GSK Investigational Site
Bochum, Nordrhein-Westfalen 44787
GermanySite Not Available
GSK Investigational Site
Solingen, Nordrhein-Westfalen 42651
GermanySite Not Available
GSK Investigational Site
Witten, Nordrhein-Westfalen 58452
GermanySite Not Available
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein 22927
GermanySite Not Available
GSK Investigational Site
Berlin, 10787
GermanySite Not Available
GSK Investigational Site
Hamburg, 20253
GermanySite Not Available
GSK Investigational Site
Barnaul, 656 045
Russian FederationSite Not Available
GSK Investigational Site
Chelyabinsk, 454106
Russian FederationSite Not Available
GSK Investigational Site
Moscow, 105 077
Russian FederationSite Not Available
GSK Investigational Site
St. Petersburg, 197022
Russian FederationSite Not Available
GSK Investigational Site
Northwood, Middlesex HA6 2RN
United KingdomSite Not Available
GSK Investigational Site
Phoenix, Arizona 85006
United StatesSite Not Available
GSK Investigational Site
Lebanon, New Hampshire 03756
United StatesSite Not Available
GSK Investigational Site
Albany, New York 12205
United StatesSite Not Available
GSK Investigational Site
Columbus, Ohio 43215
United StatesSite Not Available
GSK Investigational Site
Medford, Oregon 97504
United StatesSite Not Available
GSK Investigational Site
Gaffney, South Carolina 29340
United StatesSite Not Available
GSK Investigational Site
Greenville, South Carolina 29615
United StatesSite Not Available
GSK Investigational Site
Spartanburg, South Carolina 29303
United StatesSite Not Available
GSK Investigational Site
Union, South Carolina 29379
United StatesSite Not Available
GSK Investigational Site
Kingwood, Texas 77339
United StatesSite Not Available
GSK Investigational Site
Richmond, Virginia 23229
United StatesSite Not Available
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