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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT06122051
Eligibility Criteria:
Part A: Real-time paired DCR and Spirometry in Healthy cohort with no underlying respiratory diagnosis
Inclusion criteria:
* Age: ≥ 17 years old and \<\_ 50 years old
* No underlying respiratory illness (chronic or acute). Individuals with an Asthma diagnosis requiring short-acting bronchodilators only will be eligible
* Able to provide informed consent
Exclusion criteria:
General exclusion criteria:
Any of:
* Potentially pregnant or lactating
* Inability to provide informed consent
* Unable or unwilling to sit to perform Dynamic chest x-ray/Spirometry in the radiology department
* Unable or unwilling to follow Spirometry breathing instructions (e.g., holding breath or taking a deep breath)
* Unable to perform reproducible spirometry and/or full pulmonary function studies within American Thoracic Society and European Society joint criteria
* Significant radiation exposure within the last year (for example, numerous CT scans of chest)
* Involved, either currently or recently, in other studies involved non-routine exposure to sources of ionising radiation
* Any serious or active medical or psychiatric illness, which in the opinion of the investigators, would interfere with subject treatment, assessment, or compliance with the protocol
* Inability to complete spirometry in 20 seconds.
* Current Chest infection
Spirometry exclusion criteria
Any of:
* Unstable cardiovascular status, recent myocardial infarction or pulmonary embolism (within 6 weeks)
* Haemoptysis of unknown aetiology (within 6 weeks)
* Pneumothorax (present, or occurring within 6 weeks)
* Within 24 hours of bronchoscopy
* Thoracic, abdominal or cerebral aneurysm
* Recent eye surgery or increased intraocular pressure
* Recent thoracic or abdominal surgery
* Acute nausea, vomiting or diarrhoea
* Pregnancy
* Undergoing treatment for tuberculosis
Part B: Real-time paired DCR and spirometry in a CF subgroup
Inclusion criteria:
* Age: ≥ 17 years old and
* Attending the adult CF Unit at Liverpool heart and Chest Hospital and
* Confirmed CF diagnosis (positive sweat test in childhood and by genotyping) and
* Able to provide informed consent
General exclusion criteria, same as Group A (see above) plus:
* Recipient of Lung transplant
* Current exacerbation Spirometry exclusion criteria (same as for Group A, see above)
Sex:
ALL
Minimum Age:
17 Years
Maximum Age:
50 Years
Study:
NCT06122051
Study Brief:
Protocol Section:
NCT06122051