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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Hypertonic Saline inhalation is thought to increase mucociliary clearance of the airways
Radboud University Medical Center
Nijmegen, Netherlands
RECRUITINGChange in health-related quality of life
Measured by the Quality of Life - Bronchiectasis (QOL-B) with NTM module questionnaire at baseline, after 4, 8 and 12 weeks. The QOL-B asks the participant to subjectively rank their symptoms using a 4 scale base ranging from "a lot of difficulty" to "no difficulty", "always" to "never", "completely true" to "not at all true" and "a lot" to "not at all" for 8 domains: physical/role/emotional/social functioning, vitality, treatment burden, health perception and respiratory symptoms. The NTM-module also asks participants to subjectively rank eating problems, body image, digestive symptoms, and NTM symptoms on a 4 scale base.
Time frame: 12 weeks
Change in health-related quality of life
Measured by the PROMIS Fatigue 7a short form at baseline, after 4, 8 and 12 weeks. This questionnaire assesses self-reported fatigue over the past seven days on a 5 scale base ranging from never (1) to always (5). The lowest possible raw score (indicating the highest subjective level of fatigue) is 7; and the highest possible raw score (indicating the lowest subjective level of fatigue) is 35.
Time frame: 12 weeks
Sputum culture conversion
A conversion from positive sputum cultures at baseline to negative sputum cultures after study treatment, defined by two or more negative sputum cultures sampled a week apart.
Time frame: 12 weeks
Change in semi-quantitative culture results
Change in acid fast bacilli (AFB) smear determined by auramine staining
Time frame: 12 weeks
Change in semi-quantitative culture results
Change in sputum culture time-to-positivity
Time frame: 12 weeks
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(Serious) Adverse Events as assessed by CTCAE v5.0
Number and severity of (serious) Adverse Events as assessed by CTCAE
Time frame: 12 weeks
Treatment failure
Progression of disease that requires the start of antimycobacterial treatment as per the treating physician's discretion.
Time frame: 12 weeks
Change in pulmonary function parameters
Forced expiratory volume in 1 second (FEV1; L), Forced Vital Capacity (FVC; L), Inspiratory Capacity (IC; L), Functional Residual Volume (FRC; L) and Total Lung Capacity (TLC; L).
Time frame: 12 weeks
Change in pulmonary function parameters
Tiffeneau index (FEV1/FVC; %)
Time frame: 12 weeks
Change in physical function capacity
Change in 6-Minute Walking Distance (6MWD).
Time frame: 12 weeks
Change in inflammatory serum biomarkers
Change in C-reactive protein (CRP).
Time frame: 12 weeks
Change in inflammatory serum biomarkers
Erythrocyte Sedimentation Rate (ERS)
Time frame: 12 weeks
Change in inflammatory serum biomarkers
White blood cell count.
Time frame: 12 weeks
Therapy adherence
Self-reported therapy adherence expressed as percentage taken of total HSi administrations.
Time frame: 12 weeks
Change in self-reported health status
Change in the Nijmegen Clinical Screening Instrument (NCSI) from baseline to 12 weeks. The NCSI evaluates clinical, social and emotional self-reported measures, serves as a tool for an individualized treatment plan and can be repeated regularly to monitor the treatment effect
Time frame: 12 weeks