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:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT01002534
Eligibility Criteria:
Inclusion Criteria:
* Cystic fibrosis patients homozygous for the F508del mutation as confirmed by a genetic test
* Aged 14 years and older
* Male and female
* FEV1 \>50% of predicted normal
Exclusion Criteria:
* Acute respiratory tract infection or pulmonary exacerbation requiring antibiotic intervention within 2 weeks of visit 1
* Any condition prohibiting the correct measurement of the NPD
* Active or passive smoking
* Planned treatment or treatment with another investigational drug or therapy within 1 month prior to randomisation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT01002534
Study Brief:
Protocol Section:
NCT01002534