A randomized controlled trial on hypertonic saline inhalation in patients with nodular-bronchiectatic Mycobacterium avium complex pulmonary disease

Phase 4

Recruiting

Conditions: Nontuberculous mycobacterial lung disease
10028440
10024970
Atypical mycobacterial infection

Registration Number: NL-OMON51731

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Age > 18 years;
- Nodular-bronchiectatic M. avium complex lung disease (in accordance with 2020
ATS diagnostic criteria) with >=1 positive culture collected in the previous 4
months;
- Signed and dated patient informed consent.

Exclusion Criteria

- Antimycobacterial treatment in the past 6 months
- Current HSi use
- Clinical relevant asthma or bronchial bronchial hyperresponsiveness that is
judged to be a contra-indication for HSi.
- HIV / Cystic Fibrosis / active (pulmonary) malignancy requiring treatment in
previous 6 months / active tuberculosis fungal or nocardial disesae
- Former adverse reaction to HSi
- Fibro-cavitary NTM lung disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in clinical efficacy measures after 3 months of therapy, measured by<br /><br>the Quality of Life-Bronchiectasis (QOL-B) with NTM module and the PROMIS<br /><br>Fatigue Short Form questionnaires.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in the following parameters after 3 months of therapy:<br /><br><br /><br>- Sputum culture conversion and change in the bacterial load, measured by<br /><br>auramine staining and time-to-positivity<br /><br>- Adverse events, adverse device effects, therapy adherence<br /><br>- Treatment failure (defined as the need to start antimycobacterial treatment<br /><br>during the study)<br /><br>- Lung function parameters FEV1 (L), FVC (L), IC (L), FRC (L), TLC (L)<br /><br>- 6-minute walking distance<br /><br>- C-reactive protein (CRP), Erythrocyte Sedimentation Rate (ESR), white blood<br /><br>cell count<br /><br>- Nijmegen Clinical Screening Instrument (NCSI)</p><br>