- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04494334
Development of Airway Absorption Sampling Methods (FIBRO-SAM)
Development of Airway Absorption Sampling Methods for Biomarker Assessment in Probable Idiopathic Pulmonary Fibrosis (IPF) Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Contacts and Locations
Study Contact
- Name: Melissa Wickremasinghe
- Phone Number: 02033121344
- Email: melissa.wickremasinghe@nhs.net
Study Contact Backup
- Name: Trevor Hansel
- Phone Number: 00442033125733
- Email: t.hansel@imperial.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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
Description
Inclusion Criteria:
- 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
- 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
Inclusion criteria for Sarcoidosis
- 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
Inclusion criteria for Healthy Volunteers
- 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
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
Blood samples and Nasosorption sampling
|
Sarcoidosis,
Patients with sarcoidosis who will be having bronchoscopy as part of their clinical diagnostic work up
|
Blood samples and Nasosorption sampling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline Bronchoscopy visit
|
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
|
Baseline Bronchoscopy visit
|
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.
|
Baseline Bronchoscopy visit
|
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.
|
Baseline Bronchoscopy visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of Periostin in nasosorption samples within and across the 3 groups of participants
Time Frame: Through study completion, an average of 1 year
|
Comparisons will be made of airways levels of biomarker/mediator periostin between patients with IPF and sarcoidosis and health volunteers.
|
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
|
Comparisons will be made of airways levels of biomarker/mediator surfactant protein D (SPD) between patients with IPF and sarcoidosis and health volunteers.
|
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
|
Comparisons will be made of airways levels of biomarker/mediator CCL18 between patients with IPF and sarcoidosis and health volunteers.
|
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
|
Comparisons will be made of airways levels of biomarker/mediator CXCL13 between patients with IPF and sarcoidosis and health volunteers.
|
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
|
Comparison will be made of periostin levels in blood with nasosorption and bronchosorption levels across the 3 participant groups.
|
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
|
Comparison will be made of surfactant protein D (SPD levels in blood with nasosorption and bronchosorption levels across the 3 participant groups
|
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
|
Comparison will be made of CCL18 levels in blood with nasosorption and bronchosorption levels across the 3 participant groups.
|
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
|
Comparison will be made of CXCL13 levels in blood with nasosorption and bronchosorption levels across the 3 participant groups.
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Melissa Wickremasinghe, Physician
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19SM5398
- 239911 (Other Identifier: IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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