Status:
COMPLETED
Predictive Ability of the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) for Acute Exacerbations (PACE) in Patients With COPD
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Brief Summary
Chronic Obstructive Pulmonary Disease (COPD) is a major health concern, with a substantial impact on a patient's life. However, the impact of COPD is currently under-recognised and, as a result, COPD ...
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD) is a major health concern, with a substantial impact on a patient's life. However, the impact of COPD is currently under-recognised and, as a result, COPD ...
Eligibility Criteria
Inclusion
- Type of subject: Outpatients
- Informed consent: Subjects must give their signed and dated written informed consent to participate.
- Gender: Male or Female
- Age: 40 years of age or older at Visit 1
- COPD diagnosis: Documented diagnosis of COPD at least 6 months prior to Visit 1 in accordance with the following definition by the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guideline: Post bronchodilator FEV1/FVC \< 0.7.
- History of exacerbations: At least one COPD exacerbation which required the use of any additional treatment in the last 12 months prior to Visit 1.
- For subjects who were diagnosed between 6 to 12 months prior to Visit 1, they should have at least one COPD exacerbation that required the use of any additional treatment since diagnosis.
- Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years.
Exclusion
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study
- Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if COPD is the current diagnosis.
- Non-compliance: Subjects unable to comply with any aspect of this study protocol or scheduled visits to the study centre
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01254032
Start Date
August 1 2010
End Date
November 1 2011
Last Update
August 18 2016
Active Locations (19)
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1
GSK Investigational Site
Concord, New South Wales, Australia, 2137
2
GSK Investigational Site
Woolloongabba, Queensland, Australia, 4102
3
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
4
GSK Investigational Site
Guangzhou, Guangdong, China, 510080