Idiopathic Pulmonary FibrosisFIBRO-SAMNCT04494334
Development of Airway Absorption Sampling Methods
An observational study of Idiopathic Pulmonary Fibrosis and Sarcoidosis, run by Imperial College London.
Trial summary
The study will measure airway inflammation in probable idiopathic pulmonary fibrosis (IPF) and sarcoidosis as well as in healthy volunteers. This can help understand the molecular basis of these diseases, why these diseases happen, and what makes patients develop lung fibrosis. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Sarcoidosis
- What is being tested?
- Bronchoscopy for Probable Idiopathic Pulmonary Fibrosis and Sarcoidosis
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Jan 2022
- 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 40 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with probable IPF and Sarcoidosis will be included. Patients with probable IPF and Sarcoidosis will be selected from clinic lists for patients undergoing bronchoscopy as part of their clinical assessment, and they will be invited to participate in this study that involves additional sampling for clinical research purposes. Probable IPF patients must have Usual Interstitial Pneumonitis (UIP) on CT scan and will be sub classified by gas transfer (DLco corrected for haemoglobin as detailed below; * Mild (DLco>60) * Moderate (DLco 40-60) * Severe (DLco<40) Healthy volunteers (age/sex matched, non-smoking, without a clinical history of atopy). The patient populations will include: * Probable Idiopathic Pulmonary Fibrosis (IPF), n=30 * Sarcoidosis patients, n=15 * Healthy Volunteers n=15
Who may be able to join
- Inclusion Criteria for Probable Idiopathic Pulmonary Fibrosis (IPF)
- Adult male or female patients aged 40 to 85 years
- Women of childbearing age should not be pregnant, planning to get pregnant or breast-feeding.
- Command of the English language to be able to give informed consent.
- Probable IPF requiring bronchoscopy to confirm the diagnosis, agreed within the local multi-disciplinary team (MDT).,according to the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ American Latin Thoracic Association (ATS/ERS/JRS/ALAT) guidelines (2018) (3)
- IPF disease diagnosis within the past 5 years
Show all 52Show fewer
- Usual Interstitial Pneumonia (UIP) on HRCT scan.
- Recent lung function criteria:
- Forced vital capacity (FVC) >40% of predicted value.
- Carbon monoxide diffusing lung capacity (DLco) corrected for haemoglobin >30% of predicted value
- Adult male or female patients aged 18 years and over
- Women of childbearing age should not be pregnant, planning to get pregnant or breast-feeding.
- Clinical symptoms, CT scan and biopsy diagnosis of sarcoidosis
- Patients with lung parenchymal disease and pulmonary stage II or more
- Recent lung function criteria
- FVC>50% predicted
- DLCO >40% predicted
- Age between 40 to 85 years, age and sex to match the group with IPF
- Healthy subjects without any diseases that may cause inflammation
- Women of childbearing age should not be pregnant, planning to get pregnant or breast-feeding.
- Currently non-smokers: see exclusion criteria
- Exclusion Criteria:Exclusion Criteria for probable IPF and Sarcoidosis Patients
- Respiratory Conditions other than IPF or sarcoidosis:
- Confirmed diagnosis of occupational lung disease
- Drug-induced lung disease or hypersensitivity pneumonitis
- Lung and systemic autoimmune disease including connective tissue disease. Patients with an auto-immune profile considered diagnostic for a specific connective tissue disease will be excluded, even in the absence of systemic symptoms. Non-specific rises in auto antibodies e.g. rheumatoid factor; anti-nuclear antibody etc. will not be used to exclude individuals from the study.
- Asbestosis or other asbestos related disease (pleural plaques, mesothelioma, asbestos pleural effusions)
- Granulomatous lung disease.
- Pulmonary artery hypertension (PAH) requiring a specific treatment.
- Predominant chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second /forced vital capacity (FEV1/FVC) <0.70.
- Patients with active tuberculosis or incompletely treated latent tuberculosis infection
- Lung cancer
- Upper respiratory tract infections in the past 6 weeks.
- Systemic Conditions
- History of vasculitis, autoimmune or connective tissue disease
- Known human immunodeficiency virus (HIV) or chronic viral hepatitis
- Clinically significant diseases (other than IPF or sarcoidosis) that may alter respiratory biomarkers: including other respiratory, gastrointestinal, endocrine, haematological, cardiovascular, genitourinary, skin or neurological diseases.
- Recent or ongoing malignant diseases.
- Significant nasal anatomical defects preventing nasal sampling: including hypertrophy of turbinates, major septum deviation, nasal polyposis or recurrent sinusitis and nasal mucosal defects
- Bronchoscopy Contraindications
- Any contra-indication to bronchoscopy as set out in British Thoracic Society guidelines (34)
- Smoking
- A detailed smoking history will be taken from all participants: to include total pack years, smoking in the past year, and smoking in the past 2 weeks.
- The history will include cigarettes, pipe smoking, cigars, vaping, and shisha. Any form of smoking is not permitted within 2 weeks of bronchoscopy.
- 5.4.2 Exclusion Criteria for Healthy Volunteers
- Current inflammatory/ immunological conditions. Any clinically significant diseases that may alter respiratory biomarkers: including respiratory, gastrointestinal, endocrine, haematological, cardiovascular, genitourinary, skin or neurological diseases.
- Recent or ongoing malignant diseases.
- Significant nasal anatomical defects preventing nasal sampling: including hypertrophy of turbinates, major septum deviation, nasal polyposis or recurrent sinusitis and nasal mucosal defects
- Upper respiratory tract infections in the past 6 weeks.
- Cigarette smoking:
- no cigarettes in the last 2 weeks not more than 10 cigarettes in the past year <10 year lifetime pack history of smoking
- -
Who cannot join
None listed.
About this study
Official title: Development of Airway Absorption Sampling Methods for Biomarker Assessment in Probable Idiopathic Pulmonary Fibrosis (IPF) Patients
The study will measure airway inflammation in probable idiopathic pulmonary fibrosis (IPF) and sarcoidosis as well as in healthy volunteers. This can help understand the molecular basis of these diseases, why these diseases happen, and what makes patients develop lung fibrosis. These insights should one day help to monitor patients and aid in their diagnosis and treatment.
Read the detailed description
IPF is a progressive disease caused by irreversible scarring of the lung, and disease trajectory is not easily predicted based on clinical measurements. Biomarkers reflective of molecular pathways involved in IPF may help inform patient trajectory, but have been difficult to identify in circulation due to the disease manifesting in the lung. The study team will measure biomarkers from Probable IPF patients, sarcoidosis patients, and healthy volunteers using novel sampling methods involving absorption of upper and lower airway fluids. These novel sampling methods may enable less invasive and potentially more sensitive methods to detect disease activity and will be performed in IPF and sarcoidosis patients during a routine bronchoscopy procedure. The study team will compare the levels of biomarkers that have been shown to be predictive of disease course in airway fluids of probable IPF patients versus sarcoidosis and healthy controls. This study may help understand the molecular basis of IPF, and improve the understanding of diagnosis and treatment.
- Conditions
- Idiopathic Pulmonary Fibrosis, Sarcoidosis
- Being tested
- Bronchoscopy for Probable Idiopathic Pulmonary Fibrosis and Sarcoidosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy for Probable Idiopathic Pulmonary Fibrosis and SarcoidosisProcedure or surgery
Blood samples and Nasosorption sampling
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | These will be age matched healthy volunteers (n=15) who will not undergo bronchoscopy | |
| Probable Idiopathic Pulmonary Fibrosis | Patients with probable IPF, who will be having bronchoscopy as part of their clinical diagnostic work up Receives: Procedure: Bronchoscopy for Probable Idiopathic Pulmonary Fibrosis and Sarcoidosis | |
| Sarcoidosis, | Patients with sarcoidosis who will be having bronchoscopy as part of their clinical diagnostic work up Receives: Procedure: Bronchoscopy for Probable Idiopathic Pulmonary Fibrosis and Sarcoidosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of the of biomarker/mediator surfactant protein D (SPD) in bronchial Lining fluid in IPF and sarcoidosis patients
Comparisons will be made of bronchial lining fluid levels of biomarker/mediator surfactant protein D (SPD), in patients with IPF and sarcoidosis.
Measured: Baseline Bronchoscopy visit
Levels of the biomarker/mediator CCL18 in bronchial Lining fluid in IPF and sarcoidosis patients.
Comparisons will be made of bronchial lining fluid levels of biomarker/mediator CCL18 in patients with IPF and sarcoidosis
Measured: Baseline Bronchoscopy visit
Levels of the biomarker/mediator CXCL13 in bronchial Lining fluid in IPF and sarcoidosis patients.
Comparisons will be made of bronchial lining fluid levels of biomarker/mediator CXCL13 in patients with IPF and sarcoidosis.
Measured: Baseline Bronchoscopy visit
Levels of the of biomarker/mediator periostin in bronchial Lining fluid in IPF and sarcoidosis patients.
Comparisons will be made of bronchial lining fluid levels of biomarker/mediator periostin in patients with IPF and sarcoidosis.
Measured: Baseline Bronchoscopy visit
Secondary outcomes (8)
Levels of Periostin in nasosorption samples within and across the 3 groups of participants
Comparisons will be made of airways levels of biomarker/mediator periostin between patients with IPF and sarcoidosis and health volunteers.
Measured: Through study completion, an average of 1 year
Levels of surfactant protein (SPD) in nasosorption samples within and across the 3 groups
Comparisons will be made of airways levels of biomarker/mediator surfactant protein D (SPD) between patients with IPF and sarcoidosis and health volunteers.
Measured: Through study completion, an average of 1 year
Levels of CCL18 in nasosorption samples within and across the 3 groups
Comparisons will be made of airways levels of biomarker/mediator CCL18 between patients with IPF and sarcoidosis and health volunteers.
Measured: Through study completion, an average of 1 year
Levels of CXCL13 in nasosorption samples within and across the 3 groups
Comparisons will be made of airways levels of biomarker/mediator CXCL13 between patients with IPF and sarcoidosis and health volunteers.
Measured: Through study completion, an average of 1 year
Levels of periostin in blood within and across the 3 groups of participants
Comparison will be made of periostin levels in blood with nasosorption and bronchosorption levels across the 3 participant groups.
Measured: Through study completion, an average of 1 year
Levels of surfactant protein D (SPD in blood within and across the 3 groups of participants
Comparison will be made of surfactant protein D (SPD levels in blood with nasosorption and bronchosorption levels across the 3 participant groups
Measured: Through study completion, an average of 1 year
Levels of CCL18 in blood within and across the 3 groups of participants
Comparison will be made of CCL18 levels in blood with nasosorption and bronchosorption levels across the 3 participant groups.
Measured: Through study completion, an average of 1 year
Levels of CXCL13 in blood within and across the 3 groups of participants
Comparison will be made of CXCL13 levels in blood with nasosorption and bronchosorption levels across the 3 participant groups.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Jan 2022
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Why it stopped: Study terminated by funder- terminated before CCC and recruitment- no recruitment and no data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Melissa Wickremasinghe, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494334
- Sponsor's protocol ID
- 19SM5398
- Other IDs
- 239911
- Acronym
- FIBRO-SAM
- Status last verified
- Sep 2023
- First submitted
- 9 Jun 2020
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Airway Absorption Sampling Methods for Biomarker Assessment in Probable Idiopathic Pulmonary Fibrosis (IPF) Patients
- ClinicalTrials.gov ID
- NCT04494334
- Acronym / sponsor ID
- FIBRO-SAM / 19SM5398
- Conditions
- Idiopathic Pulmonary Fibrosis, Sarcoidosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study terminated by funder- terminated before CCC and recruitment- no recruitment and no data collection
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 31 Jul 2020 (actual)
- 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.
The study will measure airway inflammation in probable idiopathic pulmonary fibrosis (IPF) and sarcoidosis as well as in healthy volunteers. This can help understand the molecular basis of these diseases, why these diseases happen, and what makes patients develop lung fibrosis. These insights should one day help to monitor patients and aid in their diagnosis and treatment.
Detailed description
IPF is a progressive disease caused by irreversible scarring of the lung, and disease trajectory is not easily predicted based on clinical measurements. Biomarkers reflective of molecular pathways involved in IPF may help inform patient trajectory, but have been difficult to identify in circulation due to the disease manifesting in the lung. The study team will measure biomarkers from Probable IPF patients, sarcoidosis patients, and healthy volunteers using novel sampling methods involving absorption of upper and lower airway fluids. These novel sampling methods may enable less invasive and potentially more sensitive methods to detect disease activity and will be performed in IPF and sarcoidosis patients during a routine bronchoscopy procedure. The study team will compare the levels of biomarkers that have been shown to be predictive of disease course in airway fluids of probable IPF patients versus sarcoidosis and healthy controls. This study may help understand the molecular basis of IPF, and improve the understanding of diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –These will be age matched healthy volunteers (n=15) who will not undergo bronchoscopy |
| Probable Idiopathic Pulmonary Fibrosis | – | Procedure: Bronchoscopy for Probable Idiopathic Pulmonary Fibrosis and SarcoidosisPatients with probable IPF, who will be having bronchoscopy as part of their clinical diagnostic work up |
| Sarcoidosis, | – | Procedure: Bronchoscopy for Probable Idiopathic Pulmonary Fibrosis and SarcoidosisPatients with sarcoidosis who will be having bronchoscopy as part of their clinical diagnostic work up |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with probable IPF and Sarcoidosis will be included. Patients with probable IPF and Sarcoidosis will be selected from clinic lists for patients undergoing bronchoscopy as part of their clinical assessment, and they will be invited to participate in this study that involves additional sampling for clinical research purposes. Probable IPF patients must have Usual Interstitial Pneumonitis (UIP) on CT scan and will be sub classified by gas transfer (DLco corrected for haemoglobin as detailed below; * Mild (DLco>60) * Moderate (DLco 40-60) * Severe (DLco<40) Healthy volunteers (age/sex matched, non-smoking, without a clinical history of atopy). The patient populations will include: * Probable Idiopathic Pulmonary Fibrosis (IPF), n=30 * Sarcoidosis patients, n=15 * Healthy Volunteers n=15
Key inclusion criteria (52 listed)
- Inclusion Criteria for Probable Idiopathic Pulmonary Fibrosis (IPF)
- Adult male or female patients aged 40 to 85 years
- Women of childbearing age should not be pregnant, planning to get pregnant or breast-feeding.
- Command of the English language to be able to give informed consent.
- Probable IPF requiring bronchoscopy to confirm the diagnosis, agreed within the local multi-disciplinary team (MDT).,according to the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ American Latin Thoracic Association (ATS/ERS/JRS/ALAT) guidelines (2018) (3)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopy for Probable Idiopathic Pulmonary Fibrosis and SarcoidosisBlood samples and Nasosorption sampling | Procedure or surgery | Probable Idiopathic Pulmonary Fibrosis, Sarcoidosis, |
Primary outcome
Levels of the of biomarker/mediator surfactant protein D (SPD) in bronchial Lining fluid in IPF and sarcoidosis patients
Time frame: Baseline Bronchoscopy visit
Comparisons will be made of bronchial lining fluid levels of biomarker/mediator surfactant protein D (SPD), in patients with IPF and sarcoidosis.
Levels of the biomarker/mediator CCL18 in bronchial Lining fluid in IPF and sarcoidosis patients.
Time frame: Baseline Bronchoscopy visit
Comparisons will be made of bronchial lining fluid levels of biomarker/mediator CCL18 in patients with IPF and sarcoidosis
Levels of the biomarker/mediator CXCL13 in bronchial Lining fluid in IPF and sarcoidosis patients.
Time frame: Baseline Bronchoscopy visit
Comparisons will be made of bronchial lining fluid levels of biomarker/mediator CXCL13 in patients with IPF and sarcoidosis.
Levels of the of biomarker/mediator periostin in bronchial Lining fluid in IPF and sarcoidosis patients.
Time frame: Baseline Bronchoscopy visit
Comparisons will be made of bronchial lining fluid levels of biomarker/mediator periostin in patients with IPF and sarcoidosis.
8 secondary outcomes
Levels of Periostin in nasosorption samples within and across the 3 groups of participants
Time frame: Through study completion, an average of 1 year
Levels of surfactant protein (SPD) in nasosorption samples within and across the 3 groups
Time frame: Through study completion, an average of 1 year
Levels of CCL18 in nasosorption samples within and across the 3 groups
Time frame: Through study completion, an average of 1 year
Levels of CXCL13 in nasosorption samples within and across the 3 groups
Time frame: Through study completion, an average of 1 year
Levels of periostin in blood within and across the 3 groups of participants
Time frame: Through study completion, an average of 1 year
Levels of surfactant protein D (SPD in blood within and across the 3 groups of participants
Time frame: Through study completion, an average of 1 year
Levels of CCL18 in blood within and across the 3 groups of participants
Time frame: Through study completion, an average of 1 year
Levels of CXCL13 in blood within and across the 3 groups of participants
Time frame: Through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- 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.
Melissa Wickremasinghe principal investigator
Physician
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Sarcoidosis, run by Imperial College London.
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 52 inclusion and 0 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: withdrawn, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of the of biomarker/mediator surfactant protein D (SPD) in bronchial Lining fluid in IPF and sarcoidosis patients (time frame: Baseline Bronchoscopy visit). The study lists 4 primary outcomes in all. 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 15 Sep 2023.