Clinical trial: Gleevec Idiopathic Pulmonary Fibrosis (IPF) Study (NCT00131274)

Eligibility criteria:
Inclusion Criteria:

          -  Clinical symptoms consistent with IPF with onset between 3 months and 36 months prior
             to screening

          -  Worsening as demonstrated by any one of the following within the past year:

               1. >10% decrease in FVC % of predicted,

               2. Worsening chest x-ray or

               3. Worsening dyspnea at rest or on exertion

          -  Age 20 -79 years of age. Subjects aged 20-50 must have diagnosis by either open or
             video-assisted thoracic surgery (VATS) lung biopsy

          -  Diagnosis must be made by (HRCT) showing definite or probable IPF AND either of the
             following:

               1. Open or VATS lung biopsy showing definite or probable usual interstitial
                  pneumonitis (UIP)

               2. Non-diagnostic transbronchial biopsy to exclude other conditions (including
                  granulomatous disease and malignancies) AND abnormal pulmonary function tests
                  (reduced FVC or decreased DLCO or impaired gas exchange with rest or exercise)
                  AND 2 of the following:

               1. Age >50 years

               2. Insidious onset of otherwise unexplained dyspnea or exertion

               3. Bibasilar, inspiratory crackles on examination

          -  FVC> 55% of predicted value at baseline

          -  DLCO > 35% of predicted value at screening

          -  PaO2 >60 mmHg (sea level) or 55 mmHg (altitude) at rest on room air

          -  Able to understand and willing to provide informed consent prior to any study
             procedures

        Exclusion Criteria:

          -  History of clinically significant environmental exposure known to cause pulmonary
             fibrosis

          -  Diagnosis of connective tissue disease

          -  FEV1/FVC ratio < 0.6 at screening (post-bronchodilator)

          -  Residual volume > 120% predicted at screening

          -  Evidence of active infection

          -  Any condition other than IPF, which, in the opinion of the site principal
             investigator, is likely to result in the death of the patient within the next year

          -  History of unstable or deteriorating cardiac or neurologic disease

          -  Women with child bearing potential

          -  Current treatment with corticosteroids, cytoxan, azathioprine, colchicines,
             pirfenidone, interferon gamma or beta, anti-tumor necrosis factor therapy or with
             endothelin receptor blockers.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 79 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