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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Royal Free London NHS Foundation Trust
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Naif S Sulaiman, PhD Candidate
• Email: naif.sulaiman.22@ucl.ac.uk
• Phone: +44 20 7794 0500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.