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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT00144859
Eligibility Criteria:
Inclusion criteria:
* Non-childbearing potential.
* Clinical diagnosis of COPD.
* Cigarette smoking history of greater than or equal to 10 pack years.
* Post-bronchodilator FEV1 to FVC ratio (FEV1:FVC) \< 0.7
* Post-bronchodilator FEV1 50% - 80% of predicted normal.
* Receiving inhaled corticosteroids for a minimum of 6 weeks prior to Screening.
* Serum CRP concentration greater than 3mg/L.
Exclusion criteria:
* Current diagnosis of asthma.
* Active tuberculosis, sarcoidosis or bronchiectasis.
* History of any type of malignancy, rheumatoid arthritis or other conditions associated with chronic inflammation.
* Clinically significant renal or hepatic disease.
* History of increased liver function tests, or patients receiving hormone replacement therapy, statins or systemic or topical corticosteroids.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00144859
Study Brief:
Protocol Section:
NCT00144859