A Randomized Controlled Trial on Hypertonic Saline Inhalation in Patients With Nodular-bronchiectatic Mycobacterium Avium Complex Pulmonary Disease
Who is this study for? Patients with nodular-bronchiectatic mycobacterium avium complex pulmonary disease
What treatments are being studied? Hypertonic Saline
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Netherlands
Radboud University Medical Center
RECRUITING
Nijmegen
Contact Information
Primary
Arthur Lemson, MSc
arthur.lemson@radboudumc.nl
+31634265743
Backup
Wouter Hoefsloot, MSc, PhD
wouter.hoefsloot@radboudumc.nl
+31612569107
Time Frame
Start Date: 2022-05-20
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 30
Treatments
Experimental: Hypertonic Saline inhalation
Participants randomized to the Hypertonic Saline inhalation arm will be prescribed a nebulizer for Hypertonic Saline Inhalation (5ml, 5.8%) two times a day for 12 weeks. Participants will also receive best supportive care for 12 weeks (see below).
No_intervention: Best supportive care
Participants randomized to the best supportive care arm will receive standard of care including management of predisposing (lung) disease, guidance in smoking cessation, respiratory physiotherapy (e.g. airway clearance), nutritional guidance, but no antimycobacterial treatment.
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center