Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease

NCT05192057 | Recruiting Phase 4

• 1 other identifier: KGx60
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nontuberculous Mycobacterial Lung Disease; Mycobacterium Avium Complex

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Secondary Outcomes (13)

• Sputum culture conversion

  12 weeks

• Change in semi-quantitative culture results

  12 weeks

• Change in semi-quantitative culture results

  12 weeks

• (Serious) Adverse Events as assessed by CTCAE v5.0

  12 weeks

• Treatment failure

  12 weeks

Study Arms (2)

Hypertonic Saline inhalation

EXPERIMENTAL

Participants randomized to the Hypertonic Saline inhalation arm will be prescribed a nebulizer for Hypertonic Saline Inhalation (5ml, 5.8%) two times a day for 12 weeks. Participants will also receive best supportive care for 12 weeks (see below).

Device: Hypertonic Saline inhalation

Best supportive care

NO INTERVENTION

Participants randomized to the best supportive care arm will receive standard of care including management of predisposing (lung) disease, guidance in smoking cessation, respiratory physiotherapy (e.g. airway clearance), nutritional guidance, but no antimycobacterial treatment.

Interventions

Hypertonic Saline inhalation DEVICE

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

Hypertonic Saline inhalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Medical Center

Nijmegen, 6225GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Mycobacterium avium-intracellulare Infection

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Arthur Lemson, MSc

CONTACT

+31634265743; arthur.lemson@radboudumc.nl

Wouter Hoefsloot, MSc, PhD

CONTACT

+31612569107; wouter.hoefsloot@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 14, 2022
• Study Start: May 20, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

NL (1)