Healthy Clinical Trial
Official title:
Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases
Nasal, tracheal and bronchial sampling of MLF in patients with idiopathic pulmonary
fibrosis(IPF), sarcoidosis, tuberculosis(TB), asthma and COPD. Similar sampling from healthy
controls for comparative data.
Aim: To characterise the molecular basis of the upper and lower airway mucosa inflammatory
response in different respiratory diseases. To assess molecular biomarkers and signatures to
see if these can aid diagnosis, stratification of these respiratory diseases. To direct
personalised medicine and rationalise therapy.
Outcome measures:Measurement of levels of inflammation, coagulation, complement activation
and fibrosis in MLF, transcriptomics from nasal curettage and airway brushings and to assess
the tolerability of absorption procedures in these patients.
Aim- To define the diagnosis, stratification and monitoring of IPF, sarcoidosis and TB,
providing targets and biomarkers for new therapy. The investigators will study asthma and
COPD patients with inflammation of the airways, and to compare with healthy control
subjects. Characterising inflammation using upper airway sampling may eventually remove the
requirement for invasive diagnostic bronchoscopy in these patients. The investigators shall
assess the presence of cytokines, chemokines, together with complement, coagulation and
fibrosis. The investigators propose to obtain opportunistic nasal, bronchial and tracheal
mucosal samples from patients with IPF, sarcoidosis and TB. The investigators will compare
these samples with healthy controls and with patients with asthma and COPD.
Objectives: Determining biomarkers and molecular signatures in terms of cytokines and
chemokines, coagulation, complement activation and fibrosis in the MLF from the range of
lung diseases Study design: This is a pilot study and the investigators shall obtain our
study group from patients attending the bronchoscopy suite, specialist respiratory clinics
and those being admitted to the wards at St Mary's Hospital under the Respiratory team. The
investigators shall recruit patients with asthma and COPD,as well as age/ sex- matched
healthy volunteers.
IPF, sarcoid and TB patients are usually undergoing bronchoscopy or endobronchial
ultrasound(EBUS) and transbronchial needle aspiration(TBNA) for diagnostic purposes. Their
diagnosis may only be confirmed after sampling is done after the bronchoscopy.
The patients included in the study will represent the following groups:
IPF at least 12 subjects Sarcoidosis at least 12 subjects TB at least 12 subjects COPD at
least 12 subjects Asthma at least 12 subjects Healthy at least 12 subjects Study visits:
Having identified patients suitable for this study, the study involves a single
bronchoscopy, during which all airway sampling takes place. The investigators will recruit
patients with asthma, COPD and healthy volunteers and they will be reimbursed for their
participation, since bronchoscopy is not routinely part of their normal clinical care. They
will be recruited by advertisements to the general public. They will be given relevant
participant information sheet regarding this study by email or post.
Participants with confirmed or suspected IPF, sarcoidosis and TB who are due for a
bronchoscopy will be identified during their routine clinical care and as part of their
diagnostic work-up, and will not receive compensation.
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