Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921943
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2021-06-04
Brief Title:
Hypertonic Saline for MAC
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Hypertonic Saline for Treatment of Pulmonary Mycobacterium Avium Complex MAC Disease
Status:
RECRUITING
Status Verified Date:
2023-12
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 MAC-HS study is a testing whether hypertonic saline helps improve symptoms and clearance of mycobacteria in patients with M avium complex lung infections
Detailed Description:
The MAC-HS study is an open label randomized control trial of hypertonic saline in pulmonary M avium complex patients Eligible patients who consent to participate will be randomized 11 to hypertonic saline or standard of care for 12 weeks All patients in the treatment group will take inhaled hypertonic saline twice daily for 12 weeks Patients may continue with other airway clearance methods ie flutter acapella valve aerobika postural drainage huff cough percussion Patients may also be treated with antibiotics targeted at other pathogens if an exacerbation occurs Patients may also be actively treated with inhaled corticosteroid at the time of enrollment with dosing adjustments during the trial discouraged Patients with disease progression at any time can be discontinued from the study treatment and treated according to ATSIDSA guidelines at the discretion of the primary investigator However such patients will still complete the 12 week final visit sputum collection and AE assessment
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?:
None
Is an FDA AA801 Violation?:
None