Phase 4 Cystic Fibrosis Trial, Recruiting NCT06242795 Sponsor: University of North Carolina, Chapel Hill Condition: Cystic Fibrosis
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Phase 4 Cystic Fibrosis Trial, Recruiting

NCT06242795
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older who are able to give informed consent to participate
  • People who have been diagnosed with bronchiectasis (a lung condition involving widened airways), confirmed by a CT scan of the chest, affecting at least 2 sections of the lung, with at least one affected section in the right lung
  • People whose lung function test (measuring how much air can be forcefully breathed out in one second) shows a result of 40% or more of what is considered normal for their age and body
  • People who have a history of bronchiectasis flare-ups (episodes that required treatment with antibiotics)
  • People who have a persistent, ongoing cough

Who may not be able to join:

  • People who have been diagnosed with cystic fibrosis, primary ciliary dyskinesia, chronic aspiration (regularly inhaling food or liquid into the lungs), or a specific type of bronchiectasis caused by scarring of the lung tissue
  • People who are unable or unwilling to stop using hypertonic saline (a saltwater inhaled treatment) for 2 weeks before their first study scan
  • People who are currently using inhaled acetylcysteine or dornase alfa (certain inhaled airway-clearing medications)
  • People who have had a lung flare-up in the 4 weeks before joining the study
  • People who have had a bad reaction to hypertonic saline in the past, such as airway tightening (bronchospasm) or coughing up blood
  • People who have coughed up a large amount of blood (more than 60 ml) in the past 3 months
  • People who need to use supplemental oxygen continuously while at rest
  • People with severe asthma, as shown by needing daily oral steroid tablets above a certain dose, using biologic (specialist injection) therapies for asthma, having been hospitalised for a severe asthma attack in the past year, or having bronchiectasis believed to be caused by long-term asthma
  • People whose airways open up significantly during lung function testing at the screening visit (confirm with trial site for exact measurements)
  • People who do not pass a hypertonic saline tolerance test at screening — for example, if they experience intolerable symptoms, or if their lung function drops significantly after a test dose and does not recover adequately
  • People who currently smoke or vape any substance, have done so in the past year, or have a significant lifetime history of cigarette smoking (more than 10 pack-years)
  • People who have had more than 2 chest CT scans in the past year, or whose combined radiation exposure from procedures is believed to exceed a certain level (confirm with trial site)
  • People who are currently participating in, or have recently participated in, another clinical trial for bronchiectasis without sufficient time since leaving that study
  • People who are pregnant

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Katherine A. Despotes, MD, University of North Carolina, Chapel Hill

Phone: 9199669198

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
23 October 2024
Est. completion
1 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Repeatability of Mucociliary Clearance (MCC) at 60 minutes; Average change in MCC60 from baseline (Visit 2 and 3), after acute treatment with HS (Visit 4), and after two weeks of treatment with HS (Visit 5)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov