Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06242795
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-01-26
Brief Title:
Hypertonic Saline in NCFB
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Effect of Hypertonic Saline on Mucociliary Clearance in Non-CF Bronchiectasis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 persons 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
The study has two main questions
1 Evaluate the repeatability MCC measures in people with non-CF bronchiectasis
2 Compare MCC at baseline before treatment with HS after a single dose of HS acute effect of HS and after two weeks of treatment with HS twice a day sustained effect of HS
Participants will participate in up to 5 study visits if completing both Aim 1 and Aim 2 1 screeningenrollment visit 2 baseline visits 1 baseline visit if only participating in Aim 2 1 visit during which first dose of HS would be administered and assessed and 1 visit after 2 weeks of treatment with HS
The study has two main questions
1 Evaluate the repeatability MCC measures in people with non-CF bronchiectasis
2 Compare MCC at baseline before treatment with HS after a single dose of HS acute effect of HS and after two weeks of treatment with HS twice a day sustained effect of HS
Participants will participate in up to 5 study visits if completing both Aim 1 and Aim 2 1 screeningenrollment visit 2 baseline visits 1 baseline visit if only participating in Aim 2 1 visit during which first dose of HS would be administered and assessed and 1 visit after 2 weeks of treatment with HS
Detailed Description:
The investigators will perform an open label single arm pilot study of 7 HS as our treatment intervention in patients with NCFB Participants will attend up to 5 study visits
The first visit V1 will be a screening visit to obtain informed consent if not already obtained confirm that subjects meet all eligibility criteria through review of medical history and clinical records and performance of a hypertonic saline tolerance test HSTT Participants meeting eligibility criteria will be enrolled in the study at that time and subsequent study visits will be scheduled
At each study visit medical history will be reviewed Pregnancy testing will be performed at all visits in participants who may become pregnant Up to two baseline MCC scans V2 and optional V3 will be performed under baseline conditions to assess variability and expectorated sputum will be collected at either visit Baseline spirometry and MBW will also be obtained at V2 and V3 and QOL-B will be assessed at V2 prior to any other study procedures that could impact their symptoms and responses
At V4 the acute response to HS on MCC will be assessed after the first dose of HS is administered at the visit marking the start of the two-week treatment period Participants will be given a supply of HS to incorporate in their airway clearance regimen twice a day for two weeks treatment period of up to 17 days depending on exact timing of when V5 falls
The evening prior to V5 patients will perform airway clearance and receive their final dose of HS The following morning they will hold airway clearance until after their study visit At V5 they will complete post-treatment QOL-B and Treatment Satisfaction Questionnaire for Medication TSQM MBW spirometry MCC 12 hours after last dose of HS to assess sustained response to HS and sputum collection
The first visit V1 will be a screening visit to obtain informed consent if not already obtained confirm that subjects meet all eligibility criteria through review of medical history and clinical records and performance of a hypertonic saline tolerance test HSTT Participants meeting eligibility criteria will be enrolled in the study at that time and subsequent study visits will be scheduled
At each study visit medical history will be reviewed Pregnancy testing will be performed at all visits in participants who may become pregnant Up to two baseline MCC scans V2 and optional V3 will be performed under baseline conditions to assess variability and expectorated sputum will be collected at either visit Baseline spirometry and MBW will also be obtained at V2 and V3 and QOL-B will be assessed at V2 prior to any other study procedures that could impact their symptoms and responses
At V4 the acute response to HS on MCC will be assessed after the first dose of HS is administered at the visit marking the start of the two-week treatment period Participants will be given a supply of HS to incorporate in their airway clearance regimen twice a day for two weeks treatment period of up to 17 days depending on exact timing of when V5 falls
The evening prior to V5 patients will perform airway clearance and receive their final dose of HS The following morning they will hold airway clearance until after their study visit At V5 they will complete post-treatment QOL-B and Treatment Satisfaction Questionnaire for Medication TSQM MBW spirometry MCC 12 hours after last dose of HS to assess sustained response to HS and sputum collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 005177D123 | OTHER_GRANT | Cystic Fibrosis Foundation | None |