Using Hypertonic Saline Inhalation to Treat Mycobacterium Avium Complex Lung Disease

A Randomized Controlled Trial on Hypertonic Saline Inhalation in Patients With Nodular-bronchiectatic Mycobacterium Avium Complex Pulmonary Disease

This study tests if inhaling Hypertonic Saline along with regular care can help people with Mycobacterium avium complex lung disease feel better and improve their quality of life.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Radboud University Medical Center (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nijmegen)
• Trial ID: NCT05192057 on ClinicalTrials.gov

What this trial studies

This trial investigates the effects of Hypertonic Saline inhalation combined with best supportive care on patients suffering from Mycobacterium avium complex lung disease. Participants will be randomly assigned to receive either Hypertonic Saline inhalation twice daily along with supportive care or supportive care alone for a duration of 12 weeks. The study aims to assess improvements in health-related quality of life, symptom burden, and mycobacterial clearance. The trial focuses specifically on patients with nodular-bronchiectatic disease, which is characterized by specific radiologic patterns.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with nodular-bronchiectatic Mycobacterium avium complex lung disease who meet specific inclusion criteria.

Not a fit: Patients with fibrocavitary MAC lung disease or those who have recently undergone antimycobacterial treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and health outcomes for patients with Mycobacterium avium complex lung disease.

How similar studies have performed: While the approach of using Hypertonic Saline inhalation is not widely tested in this specific context, similar studies have shown promise in other respiratory conditions.

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.

Where this trial is running

Nijmegen

• Radboud University Medical Center — Nijmegen, Netherlands (Recruiting)

Study contacts

• Study coordinator: Arthur Lemson, MSc

Conditions Nontuberculous Mycobacterial Lung Disease; Mycobacterium Avium Complex