NCT05192057 Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease
| NCT ID | NCT05192057 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Radboud University Medical Center |
| Condition | Nontuberculous Mycobacterial Lung Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-05-20 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2022-05-20 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Mycobacterium avium complex lung disease and compare the effect to treatment with best supportive care alone.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05192057 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nontuberculous Mycobacterial Lung Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05192057 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05192057 currently recruiting?
Yes, NCT05192057 is actively recruiting participants. Contact the research team at arthur.lemson@radboudumc.nl for enrollment information.
Where is the NCT05192057 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT05192057 clinical trial?
NCT05192057 is sponsored by Radboud University Medical Center. The trial plans to enroll 30 participants.