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 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT06242795
Eligibility Criteria:
Inclusion Criteria:
* Adults \>18 years of age able to provide informed consent
* Diagnosis of bronchiectasis confirmed on prior chest computed tomography (CT), involving at least 2 lobes, with at least one lobe of involvement in the right lung
* Forced expiratory volume in one second (FEV1) % predicted \> 40%, inclusive
* History of prior bronchiectasis exacerbations (requiring antibiotics)
* Chronic cough
Exclusion Criteria
* Diagnosis of cystic fibrosis (CF), primary ciliary dyskinesia (PCD), chronic aspiration, or predominantly traction bronchiectasis due to interstitial lung disease (ILD)
* Unable or unwilling to undergo HS washout period of 2 weeks preceding first baseline MCC scan
* Concomitant inhaled acetylcysteine or dornase alfa use
* Recent pulmonary exacerbation in preceding 4 weeks
* History of intolerance to HS (bronchospasm, hemoptysis)
* History of significant hemoptysis (\>60 ml) within the preceding 3 months
* Chronic supplemental oxygen use at rest
* Severe asthma, as reflected by need for chronic oral corticosteroids (\>10mg/day), asthma biologic therapies, hospitalization for status asthmaticus within the past year, or bronchiectasis felt to have resulted from chronic asthma
* Significant bronchodilator response (\>15% increase in FEV1 or forced vital capacity \[FVC\]) on pre-post spirometry testing during screening visit
* Failed HS tolerability test (HSTT) at screening, as indicated by:
* Intolerable symptoms after HS administration
* Decline in FEV1 % predicted by \>20% when measured 15 min after HS administration
* Decline in FEV1 % predicted between 10-20% when measured at 15 min that does not recover to within 10% of baseline without intervention 1 hour post HS test dose
* Smoking/vaping, any substance within the past year, or \>10 pack-years of cigarette use over their lifetime
* More than 2 chest CTs in the past year or a combination of procedures believed to have exposed the lungs to \>150 millisieverts (mSv)
* Current/recent participation in other interventional studies for NCFB, allowing for appropriate wash-out time
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06242795
Study Brief:
Protocol Section:
NCT06242795