Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease (SALINE)

This is an interventional treatment trial for Nontuberculous Mycobacterial Lung Disease Read More

Inclusion Criteria:

• 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 Criteria:

• 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.