Health Impact of Non-Tuberculous Mycobacteria Pulmonary Disease (NTM-PD)

NCT07192705 | Recruiting

• 2 other identifiers: 178013IRAS
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Tuberculous Mycobacteria Pulmonary Disease; Bronchiectasis

Keywords

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

Outcome Measures

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.

  Baseline (during the past week)

Secondary Outcomes (8)

• Nutritional Status

  Baseline (during the past 3 months)

• Level of depression

  Baseline (during the past 2 weeks)

• Breathlessness

  Baseline (Day of study visit)

• Lung function test

  The most recent test done within the past 2 years.

• Respiratory muscle strength

  Baseline (Day of study visit)

Other Outcomes (2)

• Daytime sleepiness

  Baseline (during the past week)

• Obstructive Sleep Apnoea (OSA)

  Baseline (during the past week)

Study Arms (2)

Non-Tuberculous Mycobacteria-Pulmonary Disease (NTM-PD)

People diagnosed with NTM-PD

Bronchiectasis

People diagnosed with bronchiectasis but no evidence for NTM pulmonary infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Participants diagnosed with NTM-PD. * Participants diagnosed with bronchiectasis without NTM pulmonary infection.

You may qualify if:

• \- 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.
• 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.
• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University College, London: lead
• Royal Free Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

RECRUITING

Related Publications (7)

• Sulaiman N, Martins B, Moreira-Sousa D, Aguiar A, Hurst JR, Brown J, Duarte R, Lipman M. Optimising non-pharmacological interventions in people with non-tuberculous mycobacterial pulmonary disease: a systematic review. ERJ Open Res. 2025 Dec 22;11(6):00533-2025. doi: 10.1183/23120541.00533-2025. eCollection 2025 Nov.

  PMID: 41438867 BACKGROUND

• Ratnatunga CN, Lutzky VP, Kupz A, Doolan DL, Reid DW, Field M, Bell SC, Thomson RM, Miles JJ. The Rise of Non-Tuberculosis Mycobacterial Lung Disease. Front Immunol. 2020 Mar 3;11:303. doi: 10.3389/fimmu.2020.00303. eCollection 2020.

  PMID: 32194556 BACKGROUND

• Winthrop KL, Marras TK, Adjemian J, Zhang H, Wang P, Zhang Q. Incidence and Prevalence of Nontuberculous Mycobacterial Lung Disease in a Large U.S. Managed Care Health Plan, 2008-2015. Ann Am Thorac Soc. 2020 Feb;17(2):178-185. doi: 10.1513/AnnalsATS.201804-236OC.

  PMID: 31830805 BACKGROUND

• Chalmers JD, Polverino E, Crichton ML, Ringshausen FC, De Soyza A, Vendrell M, Burgel PR, Haworth CS, Loebinger MR, Dimakou K, Murris M, Wilson R, Hill AT, Menendez R, Torres A, Welte T, Blasi F, Altenburg J, Shteinberg M, Boersma W, Elborn JS, Goeminne PC, Aliberti S; EMBARC Registry Investigators. Bronchiectasis in Europe: data on disease characteristics from the European Bronchiectasis registry (EMBARC). Lancet Respir Med. 2023 Jul;11(7):637-649. doi: 10.1016/S2213-2600(23)00093-0. Epub 2023 Apr 24.

  PMID: 37105206 BACKGROUND

• Kunst H, Wickremasinghe M, Wells A, Wilson R. Nontuberculous mycobacterial disease and Aspergillus-related lung disease in bronchiectasis. Eur Respir J. 2006 Aug;28(2):352-7. doi: 10.1183/09031936.06.00139005. Epub 2006 Apr 12.

  PMID: 16611651 BACKGROUND

• Lipman M, Kunst H, Loebinger MR, Milburn HJ, King M. Non tuberculous mycobacteria pulmonary disease: patients and clinicians working together to improve the evidence base for care. Int J Infect Dis. 2021 Dec;113 Suppl 1:S73-S77. doi: 10.1016/j.ijid.2021.03.064. Epub 2021 Mar 26.

  PMID: 33781905 BACKGROUND

• Haworth CS, Banks J, Capstick T, Fisher AJ, Gorsuch T, Laurenson IF, Leitch A, Loebinger MR, Milburn HJ, Nightingale M, Ormerod P, Shingadia D, Smith D, Whitehead N, Wilson R, Floto RA. British Thoracic Society guidelines for the management of non-tuberculous mycobacterial pulmonary disease (NTM-PD). Thorax. 2017 Nov;72(Suppl 2):ii1-ii64. doi: 10.1136/thoraxjnl-2017-210927. No abstract available.

  PMID: 29054853 BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Central Study Contacts

Naif S Sulaiman, PhD Candidate

CONTACT

+44 20 7794 0500; naif.sulaiman.22@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: September 25, 2025
• Study Start: August 14, 2025
• Primary Completion: February 2, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)