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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT00789867
Eligibility Criteria:
Inclusion Criteria:
* Cystic fibrosis confirmed by sweat testing or genetic analysis
* Males and females aged 16 years and above
* Forced expiratory volume in the 1st second (FEV1) \> 60% predicted values
* Clinical stability at entry
* Prepared to take effective contraceptive precautions for the duration of their participation in the study and for 3 months thereafter
* If taking regular rhDNase (pulmozyme) is willing, and considered able by independent medical carers, to withhold treatment for 24 hours before and 24 hours after the gene therapy dose
* Written informed consent obtained
* Permission to inform GP of participation in study
Exclusion Criteria:
* Infection with Burkholderia cepacia complex organisms or MRSA
* Significant nasal pathology including polyps, clinically-significant rhinosinusitis, or recurrent severe epistaxis (nose bleeds)
* Acute upper respiratory tract infection within the last 2 weeks
* Previous spontaneous pneumothorax without pleurodesis
* Recurrent severe haemoptysis
* Current smoker
* Significant comorbidity including:
1. Moderate/severe CF liver disease
2. Significant renal impairment
3. Significant coagulopathy
* Receiving 2nd line immunosuppressant drugs such as methotrexate, cyclosporine, intravenous immunoglobulin preparations
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
70 Years
Study:
NCT00789867
Study Brief:
Protocol Section:
NCT00789867