IPFRESPI-SAMNCT02807025
Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases
An observational study of IPF and Sarcoidosis, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- IPF, Sarcoidosis, Tuberculosis
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population include the following patients: Idiopathic Pulmonary fibrosis, asthma, Chronic obstructive pulmonary disease, tuberculosis,sarcoidosis and healthy
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College NHS trust , St Mary's Hospital
London, W2 1NY
Hannah Jarvis, MBBS,MRCP, 020 331 ext. 25730, hannah.jarvis@imperial.nhs.uk
Joan Nanan, BSc, 020 331 ext. 25734, joan.nanan@imperial.nhs.uk
About this study
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.
Read the detailed description
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.
- Conditions
- IPF, Sarcoidosis, Tuberculosis, Asthma, COPD, Healthy
- Medical subject headings
- Sarcoidosis, Tuberculosis, Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startSep 2015
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Onn Min Kon, MBBS,MRCP,FRCP, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807025
- Sponsor's protocol ID
- 15/LO/0444
- Acronym
- RESPI-SAM
- Status last verified
- Apr 2016
- First submitted
- 16 Jun 2016
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases
- ClinicalTrials.gov ID
- NCT02807025
- Acronym / sponsor ID
- RESPI-SAM / 15/LO/0444
- Conditions
- IPF, Sarcoidosis, Tuberculosis, Asthma, COPD, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population include the following patients: Idiopathic Pulmonary fibrosis, asthma, Chronic obstructive pulmonary disease, tuberculosis,sarcoidosis and healthy
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of levels of inflammation, coagulation, complement activation and fibrosis in MLF
Time frame: 3 years
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
1 secondary outcome
Transcriptomics on upper and lower airway cell samples
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onn Min Kon, MBBS,MRCP,FRCP principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IPF and Sarcoidosis, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Jarvis, MBBS,MRCP (020 331 ext. 25730, hannah.jarvis@imperial.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of levels of inflammation, coagulation, complement activation and fibrosis in MLF (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.