Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change in health-related quality of life [Срок оценки: 12 weeks]
• Change in health-related quality of life [Срок оценки: 12 weeks]

Вторичные конечные точки (12)

• Sputum culture conversion [Срок оценки: 12 weeks]
• Change in semi-quantitative culture results [Срок оценки: 12 weeks]
• Change in semi-quantitative culture results [Срок оценки: 12 weeks]
• (Serious) Adverse Events as assessed by CTCAE v5.0 [Срок оценки: 12 weeks]
• Treatment failure [Срок оценки: 12 weeks]
• Change in pulmonary function parameters [Срок оценки: 12 weeks]
• Change in pulmonary function parameters [Срок оценки: 12 weeks]
• Change in physical function capacity [Срок оценки: 12 weeks]
• Change in inflammatory serum biomarkers [Срок оценки: 12 weeks]
• Change in inflammatory serum biomarkers [Срок оценки: 12 weeks]
• Change in inflammatory serum biomarkers [Срок оценки: 12 weeks]
• Therapy adherence [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Radboud University Medical Center — Nijmegen

Идентификаторы

NCT: NCT05192057 · KGx60

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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