Using hypertonic saline to improve mucus clearance in bronchiectasis
Effect of Hypertonic Saline on Mucociliary Clearance in Non-CF Bronchiectasis
This study is testing if a special salt solution delivered through a nebulizer can help adults with bronchiectasis clear mucus from their lungs better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06242795 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of 7% hypertonic saline delivered via nebulizer on mucus clearance in adults with non-cystic fibrosis bronchiectasis. Participants will undergo a series of assessments to measure mucociliary clearance before and after treatment with hypertonic saline over a two-week period. The study aims to determine the repeatability of mucociliary clearance measures and compare the effects of a single dose versus sustained treatment. Participants will attend up to five study visits for evaluations and treatment administration.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a confirmed diagnosis of bronchiectasis involving at least two lobes of the lungs and a history of exacerbations.
Not a fit: Patients with cystic fibrosis, primary ciliary dyskinesia, or those who have had recent pulmonary exacerbations may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve mucus clearance and respiratory function in patients with bronchiectasis.
How similar studies have performed: Other studies have shown promising results with hypertonic saline in improving mucus clearance in similar respiratory conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Katherine A. Despotes, MD — University of North Carolina, Chapel Hill
- Study coordinator: Katherine A. Despotes, MD
- Email: katherine.despotes@unchealth.unc.edu
- Phone: 9199669198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.