Using Hypertonic Saline Inhalation to Treat Mycobacterium Avium Complex Lung Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Radboud University Medical Center
  Nijmegen, Netherlands Recruiting

Study contacts

• Study coordinator: Arthur Lemson, MSc
• Email: arthur.lemson@radboudumc.nl
• Phone: +31634265743

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using hypertonic saline to improve lung health in patients with M. avium complex infections

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.