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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT00826566
Eligibility Criteria:
Inclusion Criteria:
* COPD GOLD stage II (50% ≤ FEV1\< 80%)
* CRP plasma levels ≥ 3 mg/l
* BMI \> 20 kg/m2 and \< 30 kg/m2
* Diastolic blood pressure (DBP)=60-90 mmHg, Systolic blood pressure (SBP)=100 150 mmHg
Exclusion Criteria:
* Physical and/or mental disease or major surgery in the present or the past that might limit participation in or completion of the study
* Reported current or previous metabolic (e.g. diabetes), cardiovascular and/or renal diseases
* Known presence of a carcinoma
* Acute and/or chronic inflammatory condition such as arthritis, arthrosis, chronic colitis, etc. during three months before entry of the study
* Respiratory tract infection or exacerbation of COPD for at least 8 weeks prior to the start of the study
* Change in treatment regime of the COPD subjects for at least 8 weeks prior to the start of the study
* Use of laxatives, anti-diarrhoeal drugs and any other medication that can influence the uptake of the investigational products and/or influence their metabolism during the trial
* During the month prior to the start of the study and during the study the use of antibiotics and/or local and systemic steroidal (glucocorticoids) and non-steroidal anti-inflammatory drugs (NSAID)
* Abnormal constant dietary eating habits and a coffee consumption of less than 3 cups per day (i.e. a usual daily intake of \<400 mg caffeine).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT00826566
Study Brief:
Protocol Section:
NCT00826566