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Hypertonic Saline for MAC

Primary Purpose

Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Hypertonic saline
Azithromycin
Ethambutol
Rifampin
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nontuberculous Mycobacterial Lung Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 2 positive MAC sputum cultures in the last 12 months with at least one AFB positive sputum obtained within 12 weeks prior to randomization
  • Meet American Thoracic Society (ATS)/ Infectious Disease Society of America (IDSA) 2007 pulmonary clinical disease criteria[1]
  • Age 18 and older
  • Diagnosis of Bronchiectasis and/or bronchiectatic findings evident on chest CT report
  • Ability to provide informed consent

Exclusion Criteria:

  • Any patient who is unwilling or unable to provide consent or to comply with this protocol
  • Cavitary NTM disease
  • Patients who are currently taking or within the prior 6 months received any of the following: bedaquiline, or any component of ATS/IDSA multi-drug recommended therapy (macrolide, ethambutol, rifampin) for MAC treatment
  • Diagnosis of HIV
  • Diagnosis of Cystic fibrosis
  • Active pulmonary tuberculosis, fungal, or nocardial disease requiring treatment at screening
  • Current use of chronic systemic corticosteroids at doses of 15 mg/day for more than 3 months
  • Prior lung or other solid organ transplant

Sites / Locations

  • NYU Langone HealthRecruiting
  • Oregon Health & Science UniversityRecruiting
  • University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypertonic saline

Standard of Care

Arm Description

Patients who randomize to the hypertonic saline arm will be prescribed a nebulizer device to nebulize hypertonic saline (7%) twice daily for 12 weeks. Hypertonic saline (3%) can be prescribed in the case of poor tolerability of the 7% solution.

Patients who randomize to the standard of care arm will receive treatment for pulmonary MAC based on the approved ATS/IDSA guidelines. Changes to standard of care regimen may be made based on the investigator's discretion.

Outcomes

Primary Outcome Measures

Culture conversion
At least two negative AFB cultures on different days.

Secondary Outcome Measures

Semi-quantitative culture results
Evaluate acid fast bacilli (AFB) smear results to see if there is a decreased mycobacterial load (i.e. AFB smear 4+ decreasing to 3+).

Full Information

First Posted
June 4, 2021
Last Updated
January 27, 2023
Sponsor
Oregon Health and Science University
Collaborators
NTM Info & Research, Inc., University Health Network, Toronto, New York University
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1. Study Identification

Unique Protocol Identification Number
NCT04921943
Brief Title
Hypertonic Saline for MAC
Official Title
Hypertonic Saline for Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
NTM Info & Research, Inc., University Health Network, Toronto, New York University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 1:1 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 (i.e. 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 ATS/IDSA guidelines at the discretion of the primary investigator. However, such patients will still complete the 12 week final visit, sputum collection and AE assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypertonic saline
Arm Type
Experimental
Arm Description
Patients who randomize to the hypertonic saline arm will be prescribed a nebulizer device to nebulize hypertonic saline (7%) twice daily for 12 weeks. Hypertonic saline (3%) can be prescribed in the case of poor tolerability of the 7% solution.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Patients who randomize to the standard of care arm will receive treatment for pulmonary MAC based on the approved ATS/IDSA guidelines. Changes to standard of care regimen may be made based on the investigator's discretion.
Intervention Type
Drug
Intervention Name(s)
Hypertonic saline
Intervention Description
Nebulizing with 7% hypertonic saline twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Standard of care
Intervention Type
Drug
Intervention Name(s)
Ethambutol
Intervention Description
Standard of care
Intervention Type
Drug
Intervention Name(s)
Rifampin
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
Culture conversion
Description
At least two negative AFB cultures on different days.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Semi-quantitative culture results
Description
Evaluate acid fast bacilli (AFB) smear results to see if there is a decreased mycobacterial load (i.e. AFB smear 4+ decreasing to 3+).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 2 positive MAC sputum cultures in the last 12 months with at least one AFB positive sputum obtained within 12 weeks prior to randomization Meet American Thoracic Society (ATS)/ Infectious Disease Society of America (IDSA) 2007 pulmonary clinical disease criteria[1] Age 18 and older Diagnosis of Bronchiectasis and/or bronchiectatic findings evident on chest CT report Ability to provide informed consent Exclusion Criteria: Any patient who is unwilling or unable to provide consent or to comply with this protocol Cavitary NTM disease Patients who are currently taking or within the prior 6 months received any of the following: bedaquiline, or any component of ATS/IDSA multi-drug recommended therapy (macrolide, ethambutol, rifampin) for MAC treatment Diagnosis of HIV Diagnosis of Cystic fibrosis Active pulmonary tuberculosis, fungal, or nocardial disease requiring treatment at screening Current use of chronic systemic corticosteroids at doses of 15 mg/day for more than 3 months Prior lung or other solid organ transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Bouchat
Phone
503-494-1859
Email
johdanie@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Haley Miller
Phone
503-346-1548
Email
millehal@ohsu.edu
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Levinger
Phone
212-263-7951
Email
Amy.Levinger@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Doreen Addrizzo-Harris, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Bouchat
Phone
503-494-2568
Email
johdanie@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Gina Megson, MPH
Phone
(503) 494-2565
Email
megson@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Kevin L Winthrop, MD, MPH
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
ON M5G
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matty Mehrabi
Phone
416-603-5726
Email
Matty.Mehrabi@uhn.ca
First Name & Middle Initial & Last Name & Degree
Theodore Marras, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypertonic Saline for MAC

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