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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05192057
Study type Interventional
Source Radboud University
Contact Arthur Lemson, MSc
Phone +31634265743
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date February 2022
Completion date May 2024

See also
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Recruiting NCT04287049 - A Study of Standard Drugs for Mycobacterium Avium Complex Phase 2
Recruiting NCT03672630 - Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease Phase 2/Phase 3
Recruiting NCT04685720 - A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients N/A
Completed NCT00598962 - Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease Phase 4
Recruiting NCT02968212 - Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Phase 2