Using hypertonic saline to improve mucus clearance in bronchiectasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.