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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT01081392
Eligibility Criteria:
Inclusion Criteria:
* healthy volunteer, non-smoking or ex-smoker \>1mth and \<10packs/year
* normal ECG
* normal lab values for hematology, ionogram, AST, ALT, alk phosphatases, urea, creatinine and CRP
* FEV1/forced vital capacity \>0.7 and FEV1\>80% of predicted value
* able to produce valid sputum following induction (\>=50% viable cells, \<50% squamous cells and \<60% neutrophils)
* females must be using contraception
* written informed consent
Exclusion Criteria:
* infection within 14 days
* history of bronchial asthma
* obstructive respiratory condition with FEV1 \<70% of theoretical value
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01081392
Study Brief:
Protocol Section:
NCT01081392