Clinical trial: Development of Airway Absorption Sampling Methods (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

        -
No condition on gender to be admitted to the trial.

Subject must be at least 40 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea.  Other medical conditions include hypertension and osteoarthritis.  The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs.  He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs.  Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled  pulmonary fibrosis that is most predominant in the lower lobes, characterized  by the presence of asbestos bodies (golden-brown beaded rods with translucent centers).

Patient description (patient's own words): I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there.

Does the patient match the trial criteria? Entailment