Clinical trial NCT05192057: Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease
Official title: A Randomized Controlled Trial on Hypertonic Saline Inhalation in Patients With Nodular-bronchiectatic Mycobacterium Avium Complex Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Nontuberculous Mycobacterial Lung Disease
Mycobacterium Avium Complex
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The treatment of Mycobacterium avium complex (MAC) lung disease consists of best supportive care, often accompanied by long-lasting multi-drug antibiotic regimens. Two major radiologic patterns exist: nodular-bronchiectatic and fibrocavitary disease, characterized by slow and rapid progression of disease, respectively.

SALINE is an open-label, randomized, two-arm controlled study that investigates the effect of Hypertonic Saline inhalation (HSi) plus best supportive care versus best supportive care alone for 12 weeks in participants with nodular-bronchiectatic MAC lung disease. The investigators hypothesize that HSi added to best supportive care will improve health-related quality of life and reduce mycobacterial load more than best supportive care alone Participants will be randomized 1:1 to a study arm. Best supportive care comprises of management of a predisposing (lung) condition, guidance in smoking cessation, respiratory physiotherapy (e.g. airway clearance) and nutritional guidance. HSi will be administered two times daily. Antibacterial therapy against other bacterial infections and inhaled corticosteroids are allowed during the study period.

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.

Primary outcomes:
measure: Change in health-related quality of life
timeFrame: 12 weeks
measure: Change in health-related quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: Sputum culture conversion
timeFrame: 12 weeks
measure: Change in semi-quantitative culture results
timeFrame: 12 weeks
measure: Change in semi-quantitative culture results
timeFrame: 12 weeks
measure: (Serious) Adverse Events as assessed by CTCAE v5.0
timeFrame: 12 weeks
measure: Treatment failure
timeFrame: 12 weeks
measure: Change in pulmonary function parameters
timeFrame: 12 weeks
measure: Change in pulmonary function parameters
timeFrame: 12 weeks
measure: Change in physical function capacity
timeFrame: 12 weeks
measure: Change in inflammatory serum biomarkers
timeFrame: 12 weeks
measure: Change in inflammatory serum biomarkers
timeFrame: 12 weeks
measure: Change in inflammatory serum biomarkers
timeFrame: 12 weeks
measure: Therapy adherence
timeFrame: 12 weeks
measure: Change in self-reported health status
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
Study officials:
References: