Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases

NCT02807025 | Unknown

• 1 other identifier: 15/LO/0444
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IPF; Sarcoidosis; Tuberculosis; Asthma; COPD; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Transcriptomics on upper and lower airway cell samples

  3 years

Study Arms (6)

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.

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.

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.

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.

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.

Healthy

Nasal, tracheal and bronchial sampling of MLF in patients from healthy controls for comparative data.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population include the following patients: Idiopathic Pulmonary fibrosis, asthma, Chronic obstructive pulmonary disease, tuberculosis,sarcoidosis and healthy

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Imperial College NHS trust , St Mary's Hospital

London, W2 1NY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sarcoidosis; Tuberculosis; Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Onn Min Kon, MBBS,MRCP,FRCP

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Jarvis, MBBS,MRCP

CONTACT

020 331; hannah.jarvis@imperial.nhs.uk

Joan Nanan, BSc

CONTACT

020 331; joan.nanan@imperial.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 21, 2016
• Study Start: September 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 6, 2017

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)