Menu
Recruiting NCT05192057

Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease

Phase IV Interventional Nontuberculous Mycobacterial Lung Disease Mycobacterium Avium Complex

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypertonic Saline inhalation.
Who it may be relevant to
Registry conditions: Nontuberculous Mycobacterial Lung Disease, Mycobacterium Avium Complex. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Hypertonic Saline inhalation
    Hypertonic Saline inhalation is thought to increase mucociliary clearance of the airways

Primary outcome measures

  • Change in health-related quality of life [Time frame: 12 weeks]
  • Change in health-related quality of life [Time frame: 12 weeks]
Secondary outcome measures (12)
  • Sputum culture conversion [Time frame: 12 weeks]
  • Change in semi-quantitative culture results [Time frame: 12 weeks]
  • Change in semi-quantitative culture results [Time frame: 12 weeks]
  • (Serious) Adverse Events as assessed by CTCAE v5.0 [Time frame: 12 weeks]
  • Treatment failure [Time frame: 12 weeks]
  • Change in pulmonary function parameters [Time frame: 12 weeks]
  • Change in pulmonary function parameters [Time frame: 12 weeks]
  • Change in physical function capacity [Time frame: 12 weeks]
  • Change in inflammatory serum biomarkers [Time frame: 12 weeks]
  • Change in inflammatory serum biomarkers [Time frame: 12 weeks]
  • Change in inflammatory serum biomarkers [Time frame: 12 weeks]
  • Therapy adherence [Time frame: 12 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Radboud University Medical Center — Nijmegen

Identifiers

NCT: NCT05192057 · KGx60

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗