Development of Airway Absorption Sampling Methods

NCT04494334 | Withdrawn

• 2 other identifiers: 19SM5398239911
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. These insights should one day help to monitor patients and aid in their diagnosis and treatment.

Conditions

Idiopathic Pulmonary Fibrosis; Sarcoidosis

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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.

  Baseline Bronchoscopy visit

Secondary Outcomes (8)

• Levels of Periostin in nasosorption samples within and across the 3 groups of participants

  Through study completion, an average of 1 year

• Levels of surfactant protein (SPD) in nasosorption samples within and across the 3 groups

  Through study completion, an average of 1 year

• Levels of CCL18 in nasosorption samples within and across the 3 groups

  Through study completion, an average of 1 year

• Levels of CXCL13 in nasosorption samples within and across the 3 groups

  Through study completion, an average of 1 year

• Levels of periostin in blood within and across the 3 groups of participants

  Through study completion, an average of 1 year

Study Arms (3)

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

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

Procedure: Bronchoscopy for Probable Idiopathic Pulmonary Fibrosis and Sarcoidosis

Interventions

Bronchoscopy for Probable Idiopathic Pulmonary Fibrosis and Sarcoidosis PROCEDURE

Blood samples and Nasosorption sampling

Probable Idiopathic Pulmonary Fibrosis; Sarcoidosis,

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• Genentech, Inc.: collaborator

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Sarcoidosis

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Melissa Wickremasinghe

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: July 31, 2020
• Study Start: January 1, 2022
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share