Healthy Clinical Trial
— RESPI-SAMOfficial 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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion criteria for all participants- - Women of childbearing age should not be pregnant, planning to get pregnant or breastfeeding. - 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. Inclusion Criteria: - 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: - Healthy volunteer- use of anti-inflammatory meds including statins, antihistamines, NSAIDs, salicylates, anti-rheumatics, use of any OTC medications, URTI within the last six weeks, chronic inflammatory illness or CVS/ Resp disease/ systemic disease. - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College NHS trust , St Mary's Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College Healthcare NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of levels of inflammation, coagulation, complement activation and fibrosis in MLF | Determining biomarkers and molecular signatures(combination of mediators) in terms of cytokines and chemokines, coagulation, complement activation and fibrosis in the MLF from a range of lung diseases. The panel of mediators we aim to measure are as follows: Type 2 inflammation, IL-1 family and vascular injury |
3 years | |
Secondary | Transcriptomics on upper and lower airway cell samples | These samples can then be used for the analysis of cells by flow cytometry and to determine mRNA expression(transcriptomics). The following samples will be used for cell sampling: Nasal curettage, bronchial and tracheal cell sampling and Mediastinal lymph node sampling(EBUS only). Several patients who have respiratory diseases such as tuberculosis and sarcoidosis have enlargement of their mediastinal lymph nodes. |
3 years |
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