Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease
A Randomized Controlled Trial on Hypertonic Saline Inhalation in Patients With Nodular-bronchiectatic Mycobacterium Avium Complex Pulmonary Disease
Radboud University Medical Center
30 participants
May 20, 2022
INTERVENTIONAL
Conditions
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 Mycobacterium avium complex lung disease and compare the effect to treatment with best supportive care alone.
Eligibility
Inclusion Criteria3
- 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 Criteria14
- 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.
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Interventions
Hypertonic Saline inhalation is thought to increase mucociliary clearance of the airways
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05192057