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New treatment option for Nontuberculous Mycobacterial Lung Disease
Official title Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease
ClinicalTrials.gov ID: NCT07647575
What this study is testing
What is Nebulized 3% Hypertonic Saline?
Nebulized 3% Hypertonic Saline is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for nontuberculous mycobacterial lung disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This multicenter randomized controlled trial evaluates the clinical and microbiological effects of inhaled 3% hypertonic saline in treatment-naïve patients with nontuberculous mycobacterial lung disease (NTM-LD). Participants are randomized in a 1:1 ratio to either early initiation of 3% hypertonic saline for 6 months or delayed initiation consisting of normal saline inhalation during the first 3 months followed by 3% hypertonic saline during the subsequent 3 months.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults aged 18 years or older.
- Diagnosis of nontuberculous mycobacterial lung disease (NTM-LD) according to ATS/ERS/ESCMID/IDSA diagnostic criteria, including compatible clinical...
- Not receiving anti-NTM antibiotic treatment at the time of screening.
- Able and willing to provide written informed consent.
- Able to perform nebulized inhalation therapy using a mesh nebulizer at home.
You likely can't join if
- Active tuberculosis.
- Human immunodeficiency virus (HIV) infection.
- Receiving active treatment for malignancy.
- Uncontrolled asthma.
- Frequent or clinically significant hemoptysis.
- History of intolerance, bronchospasm, or hypersensitivity during inhalation testing with hypertonic saline.
See the full eligibility criteria
- Adults aged 18 years or older.
- Diagnosis of nontuberculous mycobacterial lung disease (NTM-LD) according to ATS/ERS/ESCMID/IDSA diagnostic criteria, including compatible clinical symptoms, radiographic findings, and microbiological evidence.
- Not receiving anti-NTM antibiotic treatment at the time of screening.
- Able and willing to provide written informed consent.
- Able to perform nebulized inhalation therapy using a mesh nebulizer at home.
- Active tuberculosis.
- Human immunodeficiency virus (HIV) infection.
- Receiving active treatment for malignancy.
- Uncontrolled asthma.
- Frequent or clinically significant hemoptysis.
- History of intolerance, bronchospasm, or hypersensitivity during inhalation testing with hypertonic saline.
- Inability to prepare a mesh nebulizer or perform inhalation therapy at home.
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.