Health Impact of Non-Tuberculous Mycobacteria Pulmonary Disease (NTM-PD) (NCT07192705) | Clinical Trial Compass
RecruitingNot Applicable
Health Impact of Non-Tuberculous Mycobacteria Pulmonary Disease (NTM-PD)
United Kingdom80 participantsStarted 2025-08-14
Plain-language summary
Nontuberculous mycobacteria (NTM) are environmental organisms found in soil and water. The majority do not cause human disease. When they do, this is mostly as a chronic lung infection in people with long-term lung problems such as chronic obstructive pulmonary disease (COPD), bronchiectasis, or cystic fibrosis. The number of people with NTM pulmonary disease (PD) is increasing, and its management can be complex, requiring prolonged treatment with multiple, often toxic, drugs in someone who may already be frail.
Non-drug approaches, such as airway clearance techniques, structured exercise, nutritional support and psychological care are used to help manage bronchiectasis and COPD. However, there is limited evidence about their benefit in people with NTM-PD. Also, it is not clear whether these patients' health needs are different from people with bronchiectasis alone.
The investigators want to identify the most important symptoms encountered by people with NTM-PD and patient preferences for care. The study also aims to explore whether the need for non-drug measures differs between people with and without NTM-PD who have other underlying lung disease.
The research will take place at one NHS centre and involve a single assessment of 40 people with NTM-PD not using specific antibiotics to treat their NTM and 40 people with bronchiectasis but no evidence for NTM. Following consent, and mainly using questionnaires, participants will be asked about their physical and mental health, and nutritional status. Exercise capacity, muscle strength and body muscle/fat composition will also be assessed using simple tests. The total time required will be a maximum of one hour. Recruitment to the study will last around six months.
The results will help improve understanding of specific needs of people with NTM-PD and guide clinically relevant research in this area.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 NT…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.