Health Impact of Non-Tuberculous Mycobacteria Pulmonary Disease (NTM-PD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
No confirmation of NTM-PD diagnosis.
Diagnosed with a reinfection of NTM-PD.
Started antimicrobial therapy for NTM-PD.
No diagnosis of bronchiectasis or diagnosis of bronchiectasis with NTM-PD.
Trial population
* Participants diagnosed with NTM-PD. * Participants diagnosed with bronchiectasis without NTM pulmonary infection.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: Non-Tuberculous Mycobacteria-Pulmonary Disease (NTM-PD)
Group B: Bronchiectasis
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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.Other outcomes
1
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)2
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)Sponsors and contacts
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University College, London
Lead sponsor
Royal Free Hospital NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov