Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Hypertonic Saline inhalation
DeviceHypertonic Saline inhalation is thought to increase mucociliary clearance of the airways
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Hypertonic Saline inhalationExperimental treatment 1 intervention
Group B: Best supportive careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change 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 weeks2
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 weeksSecondary outcomes
1
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 weeks2
Change in semi-quantitative culture results
Change in acid fast bacilli (AFB) smear determined by auramine staining
Time frame
12 weeks3
Change in semi-quantitative culture results
Change in sputum culture time-to-positivity
Time frame
12 weeks4
(Serious) Adverse Events as assessed by CTCAE v5.0
Number and severity of (serious) Adverse Events as assessed by CTCAE
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov