Clinical trial: Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study (NCT01110694)

Eligibility criteria:
Inclusion Criteria:

          -  Individuals over the age of 18 with a diagnosis of definite or probable IPF or
             definite or probable fibrotic NSIP as defined by the ATS/ERS consensus classification

        Exclusion Criteria:

          -  Patients with co-existent conditions known to be associated with the development of
             fibrotic lung disease will be excluded.

          -  This includes

               -  connective tissue disease

               -  suspected drug-induced lung disease

               -  asbestosis or other asbestos related disease (pleural plaques, mesothelioma,
                  asbestos pleural effusions)

               -  granulomatous disease including sarcoidosis.

          -  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.

          -  Patients with co-morbid disease that in the opinion of the investigators gives them an
             expected life expectancy of less than one year will be excluded from the study.

          -  Patients involved in clinical trials assessing novel IPF therapies will be excluded
             from enrolment in this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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