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Hypertonic Saline for Bronchiectasis

Phase 4

Recruiting

Led By Katherine A. Despotes, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of prior bronchiectasis exacerbations (requiring antibiotics once in prior year)

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

Must not have

Non-tuberculous mycobacterial infection (NTM) on NTM-directed antibiotic treatment

Significant bronchodilator response (>15% increase in FEV1 or forced vital capacity [FVC]) on pre-post spirometry testing during screening visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (visit 2) up to day 14 +/- 3 (visit 3)

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial aims to see how well a 7% hypertonic saline solution delivered through a nebulizer can help clear mucus from the lungs in individuals with bronchiectasis. The study will

Who is the study for?

This trial is for individuals with non-cystic fibrosis bronchiectasis, which means they have widened airways that make it hard to clear mucus. Participants will need to attend five study visits and undergo tests to see how well their lungs can get rid of inhaled particles.

What is being tested?

The trial is testing the effects of inhaling a saltwater solution called 7% hypertonic saline through a nebulizer. It aims to see if this treatment helps clear mucus from the lungs more effectively after one dose and after two weeks of use.

What are the potential side effects?

Inhaling hypertonic saline may cause side effects like coughing, a salty taste in the mouth, throat irritation, or chest tightness. However, these are generally mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I needed antibiotics for a lung condition flare-up once last year.

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My CT scan shows bronchiectasis in at least 2 lobes, including the right lung.

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I cough up at least 1 teaspoon of sputum daily, on most days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am being treated for a non-tuberculous mycobacterial infection.

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My lung function improved significantly after using a bronchodilator.

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I have been diagnosed with CF, PCD, chronic aspiration, or bronchiectasis due to ILD.

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I have had a lung flare-up in the last 4 weeks.

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I had a bad reaction to a breathing test with HS.

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I've had over 2 chest CTs or procedures exposing my lungs to more than 150 mSv in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (visit 2) up to day 14 +/- 3 (visit 3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (visit 2) up to day 14 +/- 3 (visit 3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (visit 2) up to day 14 +/- 3 (visit 3) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

Repeatability of Mucociliary Clearance (MCC) at 60 minutes

Secondary study objectives

Change in Forced Expiratory Volume in 1 Second (FEV1) from Baseline (mean from visit 2 and visit 3, pre-HS treatment) to Visit 5 (post-HS treatment period)

Change in Lung Clearance Index (LCI) as measured by Multiple Breath Washout (MBW) from Baseline (mean from Visit 2 and visit 3, pre-HS treatment) to Visit 5 (post-HS treatment period)

Change in Quality of life for Bronchiectasis (QOL-B) Domain Scores from Visit 3 (2nd baseline visit, pre-HS treatment) to Visit 5 (post-HS treatment period)

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