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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT05944367
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels
2. F508Del homozygous or heterozygous (F508Del with another severe CFTR mutation)
3. Age over 18 years
4. Able to provide written informed consent
5. Current exacerbation requiring inpatient or outpatient treatment at Royal Papworth Hospital.
6. Chronic infection with Pseudomonas aeruginosa, as defined as \>50% of sputum culture or cough swabs being positive in the preceding 12 months
7. Baseline FEV1 30%-with no predicted upper limit
Exclusion Criteria:
1. Patients unable to provide written informed consent
2. Patients whose clinical status precludes use of the ReCIVA (mask) Breath Sampler due to oxygen dependency or tachypnoea
3. Patients who require admission to intensive care
4. Lung transplant recipients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05944367
Study Brief:
Protocol Section:
NCT05944367