Study Details

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Hypertonic Saline in Non-CF Bronchiectasis

The purpose of this research study is to evaluate the effects of 7% hypertonic saline (HS) delivered by nebulizer on mucociliary clearance (MCC) - a test that shows the rate at which a person's lungs can clear inhaled particles. We will compare the rate of MCC at baseline (before treatment with HS), with MCC after a single dose of HS (acute treatment), and with MCC after two weeks of treatment with HS twice a day after 12 hours from the last dose of HS (sustained effect). We will also assess response to HS with other outcomes (lung function testing, changes in phlegm/mucus, and survey responses). If we find there is a sustained effect of HS, this would support the use of HS as part of airway clearance for people with bronchiectasis.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

At visit 1, you will meet the team to review your medical history and undergo lung function testing and hypertonic saline tolerance testing to make sure you qualify for the study. At visit 2, you will undergo lung function testing (spirometry and multiple breath washout), fill out a survey, and undergo a mucociliary clearance (MCC) scan. We will also collect a sputum sample if possible. Visit 3 is optional, but will repeat baseline measures of lung function and MCC scan that were also done at Visit 2. Visit 4 will measure lung function, and then after treatment with HS, a repeat MCC scan will be done to assess the short term effects of HS. Participants will then start treatment with HS twice a day for 2 weeks. Visit 5 will be after completing the 2 weeks of treatment. At that visit, we will repeat surveys, lung function testing, sputum collection, and MCC scan.

Incentives

up to $1000 for completing all 5 visits, travel and lodging reimbursement, treatment with hypertonic saline provided free during study period

In-person visits:
4-5

Total length of participation:
2-3 months

Looking for Specific Volunteers

Able to participate:

You have bronchiectasis in more than one part of your lung on imaging
Your lung funciton is within the specified range (FEV1 >40%)
You have a history of prior bronchiectasis exacerbations requiring antibiotics
You cough on a regular basis

Not eligible if:

You have a history of cystic fibrosis, primary ciliary dyskinesia, or interstitial lung disease
You have been smoking or vaping in the last year, or have a smoking history of more than 10 pack years
You are unable to tolerate HS or albuterol or levalbuterol, or you have coughed up a significant amount of blood recently
You are unable to stop taking HS or other mucus clearing medicines if you already on them
You have severe asthma, require supplemental oxygen at rest,or

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Katherine Despotes
katherine.despotes@unchealth.unc.edu

Primary Visit Location

UNC Eastowne Medical Office Building
100 Eastowne Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Katherine Despotes
Pediatrics - Pulmonology

Study Type

Clinical or Medical
Interventional

Study Topics

Chronic Conditions
Lungs and Breathing

IRB Number

23-0185

ClinicalTrials.gov

NCT06242795