An observational study in Non-Tuberculous Mycobacteria Pulmonary Disease and Bronchiectasis, sponsored by University College, London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University College, London · Observational
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.
Nontuberculous mycobacteria are environmental organisms primarily found in soil and water, including locations such as lakes, rivers, agricultural zones, and some industrial sites. Environmental changes facilitate the transport of these organisms to many different settings, including external and internal living spaces. NTM are separate from the Mycobacterium tuberculosis complex (the cause of tuberculosis) and are not the mycobacteria that cause leprosy. With around 200 species, these organisms can be classified into slow growing mycobacteria (SGM ≥ 7 days) or rapid growing mycobacteria (RGM \< 7 days), based on their growth rate in solid culture medium. M. avium, M. kansasii, M. xenopi, and M. abscessus are the most common NTM species that can cause pulmonary disease. Unlike M. tuberculosis these mycobacteria are not pathogens, but in the right setting, they can infect humans and produce clinical disease. This is most often seen in people with pre-existing lung damage due to bronchiectasis, chronic obstructive pulmonary disease (COPD), or cystic fibrosis, and NTM infection results in worsening health, and the development of a chronic respiratory illness, NTM-PD.
This study is designed to explore the impact of non-tuberculous mycobacteria-pulmonary disease (NTM-PD) on patients' health, to explore what symptoms are of most concern to people with NTM-PD and to better characterise what non-pharmacological interventions might help this patient group.
The study questions guiding this research are:
This will be accomplished by integrating validated Patient-Reported Outcome Measures (PROMs) with radiological evaluation and respiratory assessments. Additionally, a self-reported questionnaire will be used to rank the most significant symptoms associated with NTM-PD, as well as the daily living activities affected, from the patients' perspective.
The findings could reveal key differences in clinical features and symptoms between these groups, helping to optimise non-pharmacological interventions, improve treatment plans for people with NTM-PD, and highlight areas for future research.
- Age: 18 years or older, able to provide informed consent.
NTM-PD Group:
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:
OR
Bronchiectasis Group:
Exclusion Criteria:
- Age: Under 18 years of age, or unable to provide informed consent.
NTM-PD Group:
Bronchiectasis Group:
People diagnosed with NTM-PD
People diagnosed with bronchiectasis but no evidence for NTM pulmonary infection
Health Related Quality of Life
The Quality of Life - Bronchiectasis (QoL-B) questionnaire will be used to assess health-related quality of life of both groups. The Qol-B consist of 37 items questionnaire evaluating eight domains (physical function, role function, vitality, emotional function, social functions, treatment burden, health perception, and respiratory symptoms), each scored on a scale from 0 to 100, where higher score indicate better quality of life.
Time frame: Baseline (during the past week)
Nutritional Status
Mini Nutritional Assessment (MNA) will be used to assess nutritional status. The MNA consists of 6 items, each score to give a total score range of 0 to 14, where higher scores indicate better nutritional status.
Time frame: Baseline (during the past 3 months)
Level of depression
The Patient Health Questionnaire-9 (PHQ-9) will be used to screen for the level of depression. The PHQ-9 consists of 9 items, each scored from 0 to 3, giving a total score range of 0 to 27, where higher scores indicate higher level of depressive symptoms.
Time frame: Baseline (during the past 2 weeks)
Breathlessness
The Modified Medical Research Council Dyspnea Scale (mMRC) will be used to assess the level of breathlessness. The mMRC is a 5-point scale ranging from 0 to 4, where higher scores indicate more severe breathlessness.
Time frame: Baseline (Day of study visit)
Lung function test
Lung function will be assessed using routinely collected spirometry results. The following parameters will be collected: 1. Forced Vital Capacity (FVC): maximum exhaled volume after full inspiration, in litres (L). 2. Forced Expiratory Volume in one second (FEV₁): volume exhaled in the first second of forced expiration, in litres (L). 3. FEV₁/FVC ratio: proportion of FVC exhaled in the first second, in percent (%). 4. Forced Expiratory Flow 25-75% (FEF₂₅-₇₅%): average flow during the middle half of forced expiration, in litres per second (L/sec). 5. Peak Expiratory Flow Rate (PEFR): maximum flow during forced expiration,in litres per second (L/sec). 6. Tidal volume (VT): volume inhaled or exhaled during normal breathing, litres (L). 7. Vital Capacity (VC): maximum exhaled volume after full inspiration, in litres (L). Lower results reflect reduced lung function.
Time frame: The most recent test done within the past 2 years.
Respiratory muscle strength
Sniff Nasal Inspiratory Pressure (SNIP) test will be conducted to assess diaphragm and inspiratory muscle strength.
Time frame: Baseline (Day of study visit)
Physical Activity
6-minute walk test (6MWT) will be conducted to assess exercise capacity and physical activity.
Time frame: Baseline (Day of study visit)
Body composition
Bio-electrical Impedance Analysis (BIA) will be conducted to assess body composition. The BIA device will provide the following measures: * Fat-free mass (FFM): measured by the device, reported in kilograms (kg). * Body fat percentage: calculated by the device as the proportion of fat mass relative to total body weight, reported in percent (%). * Fat-free mass index (FFMI): calculated by the device as FFM divided by height squared, reported in kilograms per square metre (kg/m²). * Total body water (TBW): estimated by the device from conductivity of body tissues, repoted as volume in litres (L) and as the proportion of total body weight in percent (%). Lower FFM, FFMI, or TBW values indicate reduced nutritional or hydration status.
Time frame: Baseline (Day of study visit)
Lung condition
Radiological scans will be reviewed to assess the extent and pattern of the lung condition.
Time frame: The most recent CT scan done within the past 2 years.
Daytime sleepiness
Epworth Sleepiness Scale (ESS) will be used to assess daytime sleepiness and help identify risk for obstructive sleep apnoea (OSA). The ESS consists of 8 items, each scored from 0 to 3, giving a total score range of 0 to 24, where higher scores indicate greater daytime sleepiness. A score of 11 or above suggests increased daytime sleepiness.
Time frame: Baseline (during the past week)
Obstructive Sleep Apnoea (OSA)
STOP-Bang questionnaire will be used to screen for risk of obstructive sleep apnoea (OSA). The acronym STOP-Bang refers to the eight items assessed: Snoring, Tiredness during daytime, Observed apnoea, high blood Pressure, Body mass index, Age, Neck circumference, and Gender. The STOP-Bang consists of 8 yes/no items, giving a total score range of 0 to 8, where higher scores indicate a greater risk of OSA.
Time frame: Baseline (during the past week)
Plan to share: No
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