Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases
NCT ID: NCT02807025
Last Updated: 2017-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
72 participants
OBSERVATIONAL
2015-09-30
2017-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Idiopathic Pulmonary Fibrosis(IPF)
Nasal, tracheal and bronchial sampling of MLF in patients with idiopathic pulmonary fibrosis(IPF), sarcoidosis, tuberculosis(TB), asthma and Chronic Obstructive Pulmonary Disease (COPD). Similar sampling from healthy controls for comparative data.
No interventions assigned to this group
Sarcoidosis
Nasal, tracheal and bronchial sampling of MLF in patients with idiopathic pulmonary fibrosis(IPF), sarcoidosis, tuberculosis(TB), asthma and Chronic Obstructive Pulmonary Disease (COPD). Similar sampling from healthy controls for comparative data.
No interventions assigned to this group
Tuberculosis(TB)
Nasal, tracheal and bronchial sampling of MLF in patients with idiopathic pulmonary fibrosis(IPF), sarcoidosis, tuberculosis(TB), asthma and Chronic Obstructive Pulmonary Disease (COPD). Similar sampling from healthy controls for comparative data.
No interventions assigned to this group
Chronic Obstructive Pulmonary Disease
Nasal, tracheal and bronchial sampling of MLF in patients with idiopathic pulmonary fibrosis(IPF), sarcoidosis, tuberculosis(TB), asthma and Chronic Obstructive Pulmonary Disease (COPD). Similar sampling from healthy controls for comparative data.
No interventions assigned to this group
Asthma
Nasal, tracheal and bronchial sampling of MLF in patients with idiopathic pulmonary fibrosis(IPF), sarcoidosis, tuberculosis(TB), asthma and Chronic Obstructive Pulmonary Disease (COPD). Similar sampling from healthy controls for comparative data.
No interventions assigned to this group
Healthy
Nasal, tracheal and bronchial sampling of MLF in patients from healthy controls for comparative data.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participants should have no upper respiratory tract infections in past 6 weeks.
* Participants should have no significant cardiovascular disease.
* Body mass index (BMI) should be between 18 and 39.
* Participants with signs or symptoms of significant nasal anatomical defects including hypertrophy of turbinates, major septum deviation, nasal polyposis or recurrent sinusitis and nasal mucosal defects, injury, ulceration will not undergo nasal sampling.
* All participants will have to be able to provide informed consent.
* Healthy volunteer- no history of lung disease, age 18-65, BMI 18-39, PEF \>90%, no reversibility, no atopy, non smoker/ ex smoker with \>10PYH.
* Asthma- diagnosis of asthma, age 18-65, BMI 18-39, GINA mild, PEF \>70%, reversibility with salbutamol or positive with histamine, well controlled on asthma questionnaire(ACQ \<0.75), non smoker/ex smoker with \<10PYH.
* IPF- HRCT suggestive ofILD/IPF, age 45-80, BMI 18-39, FVC \>50%, DLCO 30-90%.
* Sarcoidosis- HRCT suggestive of sarcoidosis, age 18-95, BMI 18-39, FVC\>50%, DLC0\>30%.
* TB- same as sarcoidosis, including clinical history and/ or CT evidence of TB, age 18-65.
* COPD- diagnosis of COPD, age 45-65, age 18-39, gold stage 2, post bronchodilator FEV1 50-79%, FEV1/FVC ratio \<70%,TLCO 60-80% or emphysema on HRCT,Smoker/ex smoker with \>10PYH.
Exclusion Criteria
* Asthma- Use of inhaled corticosteroids in the last 4 weeks, use of oral steroids in the last 6 months, use of anti- inflammatory meds including statins, antihistamines, NSAIDs, salicylates, anti-rheumatics, use of any OTC medications, exacerbation requiring hospitalisation the last year, URTI within the last six months, significant CVS or inflammatory disease.
* IPF- Use of anti- inflammatory meds including statins, antihistamines, NSAIDs, salicylates, anti-rheumatics, use of oral steroids for 6 months, use of anti-fibrotic therapy( pirfendidone, nintedanib) for 6 months, FVC \< 50%, baseline spO2 \< 90%, use of any OTC medications, URTI within the last 6 weeks, significant CVS disease.
* Sarcoidosis- Same as IPF, including use of methotrexate for 6 months.
* COPD- Same as asthma volunteers and includes atopy.
* TB- Same as IPF, including use of anti-TB drugs.
18 Years
65 Years
ALL
Yes
Sponsors
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Imperial College Healthcare NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Onn Min Kon, MBBS,MRCP,FRCP
Role: PRINCIPAL_INVESTIGATOR
Imperial College Healthcare NHS Trust
Locations
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Imperial College NHS trust , St Mary's Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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15/LO/0444
Identifier Type: -
Identifier Source: org_study_id
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