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Single arm treatment group with 7% HS 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 14 ± 3 (visit 3) up to 5 weeks (visit 5)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 14 ± 3 (visit 3) up to 5 weeks (visit 5)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 14 ± 3 (visit 3) up to 5 weeks (visit 5)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 ± 3 (visit 3) up to 5 weeks (visit 5) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single arm treatment group with 7% HSExperimental Treatment1 Intervention

All study participants will receive 7% HS by nebulizer twice a day for two weeks as part of airway clearance.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,805 Total Patients Enrolled

3 Trials studying Bronchiectasis

65 Patients Enrolled for Bronchiectasis

Cystic Fibrosis FoundationOTHER

189 Previous Clinical Trials

37,190 Total Patients Enrolled

1 Trials studying Bronchiectasis

29 Patients Enrolled for Bronchiectasis

Katherine A. Despotes, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"As per clinicaltrials.gov, the current study is not actively seeking volunteers. The trial was originally listed on 2/1/2024 and last modified on 2/2/2024. While this particular trial is inactive in terms of recruitment, it's noteworthy that there are currently 36 other trials actively enrolling participants."

Answered by AI

What are the main goals being pursued in this research endeavor?

"The primary objective of this investigation is to assess the average change in MCC60 from baseline (Visit 2 and Visit 3) following acute treatment with HS (Visit 4), and after a two-week period of HS therapy (Visit 5). Secondary goals include evaluating alterations in Quality of life for Bronchiectasis (QOL-B) Domain Scores between Visit 3 (pre-HS treatment, considered as the second baseline visit) and Visit 5 (after HS treatment). The QOL-B Version 3.1 questionnaire evaluates symptomatology and health-related quality of life in individuals diagnosed with NCFB through eight domains including Physical"

Answered by AI

Is the single arm therapeutic group with a 7% healing solution approved by the FDA?

"Given that this treatment has obtained approval, our team at Power rates the safety of the single arm intervention group using a 7% hydrogel solution as a 3 on our assessment scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hypertonic Saline in NCFB

2024. "Hypertonic Saline in NCFB". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06242795.

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