Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT04494334
Eligibility Criteria:
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
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Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT04494334
Study Brief:
Protocol Section:
NCT04494334