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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT03750734
Eligibility Criteria:
Inclusion Criteria:
Bronchiectasis participants
1. Confirmed HRCT diagnosis of bronchiectasis in more than 1 lobe
2. Bronchiectasis not attributable to another cause, e.g. cystic fibrosis/ABPA/PCD
3. Absence of significant emphysema, COPD or asthma
4. Have provided written informed consent that they are willing to participate in the study prior to sample collection
COPD participants (disease controls)
1. Confirmed diagnosis of COPD according to GOLD (Global Initiative for Chronic Obstructive Lung Disease) criteria (FEV1/FVC ratio \< 0.70)
2. Absence of significant bronchiectasis on HRCT
3. Have provided written informed consent that they are willing to participate in the study prior to sample collection
Cystic fibrosis participants (disease controls)
1. Have a confirmed diagnosis of cystic fibrosis
2. Have provided written informed consent that they are willing to participate in the study prior to sample collection
Healthy controls
1. No history or diagnosis of clinically significant lung disease
2. Be a non-smoker for \> 1 year at screening and have \< 5 pack year history of smoking
3. Have provided written informed consent that they are willing to participate in the study prior to sample collection
Exclusion Criteria:
1. Any clinically significant acute illness, including recent exacerbation of lung disease requiring treatment with oral or intravenous antibiotics, in 6 weeks prior to screening
2. Any contraindication to safe bronchoscopy as judged by CI or clinical team (FEV1 \< 30% predicted, oxygen saturations \< 92% on room air etc.)
3. Any clinically significant bleeding disorder or use of anticoagulant/antiplatelet therapy that could place participants at risk of bleeding
4. Any contraindication to sedation or local anaesthetic medications used for bronchoscopy
5. Current smoking within 6 months prior to screening (defined as someone who has smoked at least one cigarette per day (or pipe, cigar, or cannabis) for ≥ 30 days within 6 months prior to screening)
6. Acute MI, acute stroke or major surgery within 6 months prior to screening
7. History of uncontrolled ischaemic heart disease that place participants at risk during bronchoscopy
8. History of ventilatory failure or hypercapnia that may complicate bronchoscopy
9. Any known active tuberculous or non-tuberculous mycobacterial infection
10. Any use of oral corticosteroids within 4 weeks of screening
11. Any systemic immunomodulatory or immunosuppressive therapy within 3 months of screening
12. Known current malignancy or current evaluation for a potential malignancy
13. Any other clinically significant medical disease that is uncontrolled despite treatment, that is likely, in the opinion of the investigators, to impact the patient's ability to safely participate in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03750734
Study Brief:
Protocol Section:
NCT03750734