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New treatment option for Bronchiectasis
Official title Hypertonic Saline in NCFB
ClinicalTrials.gov ID: NCT06242795
What this study is testing
What is 7% Hypertonic Saline via nebulization?
7% Hypertonic Saline via nebulization is an investigational medicine, given as a twice-daily inhaled treatment, being studied as a potential treatment for bronchiectasis.
Also referred to as 7% sodium chloride.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Forced expiratory volume in one second (FEV1) % predicted \> 40%, inclusive
- History of prior bronchiectasis exacerbations (requiring antibiotics)
- Chronic cough
You likely can't join if
- Diagnosis of cystic fibrosis (CF), primary ciliary dyskinesia (PCD), chronic aspiration, or predominantly traction bronchiectasis due to interstitial...
- 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
See the full eligibility 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
- 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...
- Significant bronchodilator response (\>15% increase in FEV1 or forced vital capacity [FVC]) on pre-post spirometry testing during screening visit
- Failed HS side effects 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 treatment studies for NCFB, allowing for appropriate wash-out time
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.