Health impact of non-tuberculous mycobacteria (NTM) lung disease

An Observational Cross-sectional Study Exploring Differences in Health Between People With Non-Tuberculous Mycobacteria Pulmonary Disease and People With Bronchiectasis Without NTM Pulmonary Infection.

This project will try to see which symptoms matter most and which non-drug treatments help adults with NTM lung disease.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University College, London (Academic / other)
• Locations: 1 site (London)
• Trial ID: NCT07192705 on ClinicalTrials.gov

What this trial studies

This is an observational study enrolling adults with confirmed NTM pulmonary disease to characterize symptom burden, care preferences, and the potential role of non-pharmacological interventions. Participants meeting British Thoracic Society diagnostic criteria and not currently on NTM antimicrobial therapy will provide patient-reported information, clinical data, and likely take part in interviews or questionnaires. The team will compare findings to people with bronchiectasis alone to see whether needs differ and to identify which airway clearance, exercise, nutritional, or psychological supports might be most useful. Results aim to guide future supportive-care approaches rather than test drugs or new clinical treatments.

Who should consider this trial

Good fit: Adults (18+) with confirmed NTM pulmonary disease by BTS criteria who are able to consent and are not currently or recently on NTM antimicrobial therapy are ideal candidates.

Not a fit: People already receiving active antimicrobial treatment for NTM-PD or those without confirmed NTM-PD are less likely to gain direct benefit from this observational work.

Why it matters

Potential benefit: If successful, the findings could help tailor symptom management and non-drug care to improve quality of life for people with NTM-PD.

How similar studies have performed: Non-drug approaches have shown benefit in bronchiectasis and COPD, but evidence specifically in NTM-PD is limited, so this work addresses a relatively novel evidence gap.

Eligibility criteria

Inclusion Criteria:

\- Age: 18 years or older, able to provide informed consent.

NTM-PD Group:

* Participants will be adults diagnosed with confirmed NTM-PD based on the British Thoracic Society (BTS) guidelines.
* The participant should not be on any antimicrobial therapy (at least two weeks before participation) and should not have previously received or be currently on antimicrobial therapy for NTM-PD.

  \* BTS guidelines:
* Clinical (both required):
* Pulmonary symptoms, nodular or cavitary opacities on chest radiograph, or a high-resolution CT scan that shows multifocal bronchiectasis with multiple small nodules.
* Appropriate exclusion of other diagnoses.
* Microbiological:
* A minimum of two positive expectorated sputum culture results of the same NTM species from samples collected on separate days within 12 months before recruitment.

OR

* Positive culture results from at least one bronchial wash or lavage. OR
* Transbronchial or other lung biopsy with mycobacterial histopathological features (granulomatous inflammation or AFB) and positive culture for NTM or biopsy showing mycobacterial histopathological features (granulomatous inflammation or AFB) and one or more sputum or bronchial washings that are culture-positive for NTM.

Bronchiectasis Group:

* Diagnosed with bronchiectasis, as confirmed in medical records based on clinical assessment, and radiological findings.
* Never had a history of positive culture result for NTM pulmonary infection.
* The latest NTM-negative result must be within the past 12 months from the study's start date or no earlier than 2024.

Exclusion Criteria:

\- Age: Under 18 years of age, or unable to provide informed consent.

NTM-PD Group:

* No confirmation of NTM-PD diagnosis.
* Diagnosed with a reinfection of NTM-PD.
* Started antimicrobial therapy for NTM-PD.

Bronchiectasis Group:

* No diagnosis of bronchiectasis or diagnosis of bronchiectasis with NTM-PD.
* Diagnosed with other chronic respiratory diseases considered primary conditions, rather than bronchiectasis.
* Participants with a history of NTM pulmonary infection.
* NTM-negative results obtained before 2024.

Where this trial is running

London

• Royal Free London NHS Foundation Trust — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Naif S Sulaiman, PhD Candidate

Conditions Non-Tuberculous Mycobacteria Pulmonary Disease; Bronchiectasis; NTM-PD; Non-Tuberculous Mycobacteria Lung Disease; Health Impact of NTM-PD; NTM-LD; Bronchiectasis without NTM-PD; Non-Pharmacological Intervention