RECRUITING

Hypertonic Saline in NCFB

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Conditions

BronchiectasisNon-cystic Fibrosis Bronchiectasisairway clearancemucociliary clearancehypertonic saline

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this single arm clinical trial is to evaluate the effects of 7% hypertonic saline (HS) delivered by nebulizer on clearance of mucus from the lungs in people with bronchiectasis (dilated airways) not due to cystic fibrosis. Mucociliary clearance (MCC) to measure the rate at which a person's lungs can clear inhaled particles will be assessed at baseline, and after acute (single dose) HS treatment, as well as after two weeks of treatment with HS. The study has two main questions: 1. Evaluate the repeatability MCC measures in people with non-CF bronchiectasis 2. Compare MCC at baseline (before treatment with HS), after a single dose of HS (acute effect of HS), and after two weeks of treatment with HS twice a day (sustained effect of HS). Participants will participate in up to 5 study visits if completing both Aim 1 and Aim 2: 1 screening/enrollment visit, 2 baseline visits (1 baseline visit if only participating in Aim 2), 1 visit during which first dose of HS would be administered and assessed, and 1 visit after 2 weeks of treatment with HS.

Official Title

Effect of Hypertonic Saline on Mucociliary Clearance in Non-CF Bronchiectasis

Quick Facts

Study Start:2024-10
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06242795

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults \>18 years of age able to provide informed consent
  2. * 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
  3. * Forced expiratory volume in one second (FEV1) % predicted \> 40%, inclusive
  4. * History of prior bronchiectasis exacerbations (requiring antibiotics)
  5. * Chronic cough
  6. * Diagnosis of cystic fibrosis (CF), primary ciliary dyskinesia (PCD), chronic aspiration, or predominantly traction bronchiectasis due to interstitial lung disease (ILD)
  7. * Unable or unwilling to undergo HS washout period of 2 weeks preceding first baseline MCC scan
  8. * Concomitant inhaled acetylcysteine or dornase alfa use
  9. * Recent pulmonary exacerbation in preceding 4 weeks
  10. * History of intolerance to HS (bronchospasm, hemoptysis)
  11. * History of significant hemoptysis (\>60 ml) within the preceding 3 months
  12. * Chronic supplemental oxygen use at rest
  13. * 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
  14. * Significant bronchodilator response (\>15% increase in FEV1 or forced vital capacity \[FVC\]) on pre-post spirometry testing during screening visit
  15. * Failed HS tolerability test (HSTT) at screening, as indicated by:
  16. * Intolerable symptoms after HS administration
  17. * Decline in FEV1 % predicted by \>20% when measured 15 min after HS administration
  18. * 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
  19. * Smoking/vaping, any substance within the past year, or \>10 pack-years of cigarette use over their lifetime
  20. * More than 2 chest CTs in the past year or a combination of procedures believed to have exposed the lungs to \>150 millisieverts (mSv)
  21. * Current/recent participation in other interventional studies for NCFB, allowing for appropriate wash-out time
  22. * Pregnancy
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Katherine A. Despotes, MD
CONTACT
9199669198
katherine.despotes@unchealth.unc.edu
Alex Nesbit
CONTACT
alexandria_nesbit@med.unc.edu

Principal Investigator

Katherine A. Despotes, MD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Katherine A. Despotes, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10
Study Completion Date2025-06

Study Record Updates

Study Start Date2024-10
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • airway clearance
  • mucociliary clearance
  • hypertonic saline

Additional Relevant MeSH Terms

  • Bronchiectasis
  • Non-cystic Fibrosis Bronchiectasis