Status:
RECRUITING
Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease
Lead Sponsor:
Radboud University Medical Center
Conditions:
Nontuberculous Mycobacterial Lung Disease
Mycobacterium Avium Complex
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The SALINE trial will investigate the effect of Hypertonic Saline inhalation plus best supportive care on burden of symptoms, clearance of mycobacteria and functional capacities in participants with M...
Detailed Description
The treatment of Mycobacterium avium complex (MAC) lung disease consists of best supportive care, often accompanied by long-lasting multi-drug antibiotic regimens. Two major radiologic patterns exist:...
Eligibility Criteria
Inclusion
- International guideline criteria for nodular-bronchiectatic MAC lung disease, i.e. symptomatic, nodular bronchiectatic lesions seen on thorax radiography and ≥2 positive cultures of the same MAC species or one positive culture from a bronchoalveolar lavage;
- ≥1 positive MAC sputum cultures must be collected in the previous 4 months;
- Signed and dated patient informed consent.
Exclusion
- Fibrocavitary MAC lung disease;
- Antimycobacterial treatment in the last 6 months;
- Previous MAC lung disease treatment failure, defined as persistent culture positivity despite \>6 months of guideline-recommended treatment;
- Current clinical relevant asthma or otherwise bronchial hyperresponsiveness that is judged to be a contra-indication for HSi.
- Current HSi use
- Former adverse reaction to HSi (note: former HSi use that was stopped due to a lack of clinical improvement is not an exclusion criterium);
- Hypertonic saline intolerability during the screening test inhalation
- Diagnosis of HIV;
- Diagnosis of Cystic fibrosis (CF);
- Active pulmonary malignancy (primary or metastatic) or any other malignancy requiring chemotherapy or radiotherapy within 6 months before screening or anticipated during the study period;
- Active pulmonary tuberculosis, fungal or nocardial disease requiring treatment
- Current use of chronic systemic corticosteroids at doses of 15 mg/day for more than 3 months
- Prior lung or other solid organ transplant
- Known or suspected current drug or alcohol abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the patient.
Key Trial Info
Start Date :
May 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05192057
Start Date
May 20 2022
End Date
October 1 2026
Last Update
June 26 2025
Active Locations (1)
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1
Radboud University Medical Center
Nijmegen, Netherlands, 6225GA