Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT01254032
Eligibility Criteria:
Inclusion Criteria:
1. Type of subject: Outpatients
2. Informed consent: Subjects must give their signed and dated written informed consent to participate.
3. Gender: Male or Female
4. Age: 40 years of age or older at Visit 1
5. 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.
6. 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.
7. Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years.
Exclusion Criteria:
1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study
2. Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if COPD is the current diagnosis.
3. Non-compliance: Subjects unable to comply with any aspect of this study protocol or scheduled visits to the study centre
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01254032
Study Brief:
Protocol Section:
NCT01254032