Actively Recruiting
A Randomized Controlled Trial on Hypertonic Saline Inhalation in Patients With Nodular-bronchiectatic Mycobacterium Avium Complex Pulmonary Disease
Led by Radboud University Medical Center · Updated on 2025-06-26
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of adding Hypertonic Saline inhalation to best supportive care for people with nodular-bronchiectatic Mycobacterium avium complex (MAC) lung disease. The study compares this combination to best supportive care alone over 12 weeks. The trial aims to see if Hypertonic Saline can improve quality of life and help clear the infection, as the disease can progress slowly with current treatments involving long-term antibiotics and supportive care. This randomized, open-label study assigns participants to one of two groups: one receives Hypertonic Saline inhalation twice daily using a nebulizer along with best supportive care, while the other group receives best supportive care alone. Best supportive care includes managing underlying lung conditions, advice on quitting smoking, respiratory physiotherapy, and nutritional support. The treatment period lasts 12 weeks, and antibacterial treatments for other infections and inhaled corticosteroids are allowed. Participants will be assessed at the start and end of the 12 weeks for changes in health-related quality of life, sputum culture results, lung function, physical capacity, inflammatory markers, and therapy adherence. Researchers will also monitor for adverse events and treatment failure. The study is sponsored by Radboud University Medical Center and aims to provide detailed information about how Hypertonic Saline inhalation affects symptoms and bacterial clearance in MAC lung disease.
CONDITIONS
Brief Title
Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet international guideline criteria for nodular-bronchiectatic MAC lung disease with symptoms and radiologic evidence
- Have at least 2 positive cultures of the same MAC species or one positive culture from bronchoalveolar lavage
- Have at least 1 positive MAC sputum culture collected in the previous 4 months
- Provide signed and dated informed consent
You will not qualify if you...
- Have fibrocavitary MAC lung disease
- Received antimycobacterial treatment in the last 6 months
- Experienced previous MAC lung disease treatment failure with persistent culture positivity despite more than 6 months of recommended treatment
- Have current clinically relevant asthma or bronchial hyperresponsiveness contraindicating Hypertonic Saline inhalation
- Current use of Hypertonic Saline inhalation
- History of adverse reaction to Hypertonic Saline inhalation
- Intolerability to Hypertonic Saline during screening inhalation test
- Diagnosis of HIV
- Diagnosis of cystic fibrosis
- Active pulmonary or other malignancy requiring recent or ongoing chemotherapy or radiotherapy within 6 months
- Active pulmonary tuberculosis, fungal or nocardial infection requiring treatment
- Chronic systemic corticosteroid use at doses of 15 mg/day or more for over 3 months
- Prior lung or other solid organ transplant
- Known or suspected current drug or alcohol abuse compromising safety or cooperation of the patient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either Hypertonic Saline inhalation twice daily plus best supportive care, or best supportive care alone, for 12 weeks.
Regular visits during 12 weeks for treatment monitoring
Trial Site Locations
Total: 1 location
1
Radboud University Medical Center
Nijmegen, Netherlands, 6225GA
Actively Recruiting
Research Team
A
Arthur Lemson, MSc
W
Wouter Hoefsloot, MSc, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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