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Antibiotic
Hypertonic Saline for Nontuberculous Mycobacterial Lung Disease
Phase 4
Recruiting
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 and older
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing a new way to treat M. avium complex lung infections by using hypertonic saline.
Who is the study for?
This trial is for adults over 18 with M. avium complex lung infections who meet specific lung disease criteria and have had at least two positive MAC sputum cultures in the past year. It's not for those with HIV, cystic fibrosis, certain NTM diseases, active tuberculosis or fungal infections, high-dose steroid users, organ transplant recipients, or anyone unable to consent.Check my eligibility
What is being tested?
The study examines if inhaling hypertonic saline can help reduce symptoms and improve mycobacteria clearance in patients with M. avium complex lung disease. Participants will also receive standard treatments like Azithromycin, Ethambutol, and Rifampin.See study design
What are the potential side effects?
Potential side effects may include irritation of the airways from hypertonic saline inhalation leading to coughing or wheezing; gastrointestinal issues from Azithromycin; vision problems or stomach pain from Ethambutol; and liver issues or flu-like symptoms from Rifampin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have had at least 2 positive lung infection tests in the last year.
Select...
I have been diagnosed with Bronchiectasis or it has been seen on my chest CT.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Culture conversion
Secondary outcome measures
Semi-quantitative culture results
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hypertonic salineExperimental Treatment1 Intervention
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.
Group II: Standard of CareActive Control3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypertonic saline
2017
Completed Phase 4
~1290
Find a Location
Who is running the clinical trial?
New York UniversityOTHER
226 Previous Clinical Trials
314,067 Total Patients Enrolled
Oregon Health and Science UniversityLead Sponsor
974 Previous Clinical Trials
7,385,862 Total Patients Enrolled
NTM Info & Research, Inc.UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been taking more than 15 mg/day of corticosteroids for over 3 months.You have symptoms that match the guidelines for diagnosing lung diseases set by the American Thoracic Society and Infectious Disease Society of America in 2007.I am 18 years old or older.I have been diagnosed with HIV.I have been diagnosed with Cystic Fibrosis.My condition involves lung cavities due to NTM infection.I have had at least 2 positive lung infection tests in the last year.I have taken specific antibiotics for MAC in the last 6 months.I am currently being treated for active tuberculosis or a serious fungal infection.You have symptoms that match the 2007 guidelines for diagnosing lung disease.I have been diagnosed with Bronchiectasis or it has been seen on my chest CT.I have had a lung or other solid organ transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Hypertonic saline
- Group 2: Standard of Care
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the potential adverse effects of Hypertonic saline therapy?
"Our team at Power gave Hypertonic saline a score of 3, in recognition that this medication has been approved for use and is currently undergoing Phase 4 trials."
Answered by AI
Are there any other experiments involving Hypertonic saline currently being conducted?
"Currently, 85 studies are underway to learn more about hypertonic saline with 29 of these trials in their final stage. Though numerous research centres for this particular remedy reside in Frankfurt am Main, Hessen, there is a global network of 940 locations that have clinical trials investigating Hypertonic Saline."
Answered by AI
In what conditions is Hypertonic saline most frequently utilized?
"The use of hypertonic saline is a widely accepted treatment for genital ulcer disease (GUD) and also provides relief from Chlamydia, cervicitis, and other adult ailments."
Answered by AI
Are there still vacant slots open for participants in this clinical trial?
"As per the information available on clinicaltrials.gov, this particular study is actively searching for participants and has been since May 18th 2021 with its most recent update occurring on May 27th 2022."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
California
Alabama
Other
What site did they apply to?
Oregon Health & Science University
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
3+
Why did patients apply to this trial?
I just found out I have this. I've tried 3 drugs which don't seem to work at all.
PatientReceived 1 prior treatment
I’ve tried a bunch of inhalers. They either don’t work or quit working. I really want this trial and hope it works.
PatientReceived 2+ prior treatments
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