Clinical trial: Azathioprine and Prednisone in the Treatment of Idiopathic Pulmonary Fibrosis (NCT00518310)

Eligibility criteria:
Inclusion Criteria:

          -  45 and 79 years of age.

          -  Clinical symptoms of IPF for at least 3 months.

          -  Forced vital capacity (FVC) between 50 to 90% of the predicted value.

          -  DLco at least 35% of the predicted value.

          -  PaO2 > 55 mm Hg while breathing ambient air at rest.

          -  High-resolution computed tomography (HRCT) showing definite or probable criteria of
             IPF.

        Exclusion Criteria:

          -  Clinically significant exposure to known fibrogenic agents (birds, molds, hot tubes,
             asbestos, radiation and drugs known to cause pulmonary fibrosis (amiodarone,
             nitrofurantoin, bleomicin,etc)).

          -  History of neurofibromatosis, Hermansky-Pudlak syndrome, metabolic storage disorders,
             etc.

          -  History of fever, weight loss, myalgias, arthralgias, skin rash, arthritis.

          -  Active infection within one week before enrollment.

          -  Alternative cause of interstitial lung disease.

          -  Ratio of the forced expiratory volume in one second (VEF1) to FVC of less than 0.6
             after the use of a bronchodilator.

          -  Residual volume more than 120% of the predicted value (when available).

          -  More than 20% of lymphocytes or eosinophils in bronchoalveolar lavage (BAL) (when
             available).

          -  Granulomas, infection or malignancy in the transbronchial or surgical biopsy (when
             available).

          -  Previous therapy with azathioprine, prednisolone (>0.5 mg/kg/day or more for at least
             3 months), cyclophosphamide or novel biotech drugs.

          -  Unstable cardiovascular or neurologic disease.

          -  Uncontrolled diabetes.

          -  Pregnancy.

          -  Lactation.

          -  Likelihood of death, as predicted by the investigator, within the next year.

          -  White cell blood count < 4000/mm3.

          -  Platelet count < 100000/mm3.

          -  Hematocrit < 30% or > 59%.

          -  Liver enzymes more than 3 times the upper limit of the normal range.

          -  Creatinine level > 1.5 mg/dL.

          -  Albumin level < 3 g/dL.

          -  Refusal to sign informed consent by patient or guardian.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 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