Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Hypertonic Saline inhalation
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov