Clinical trial: Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients (NCT01118221)

Eligibility criteria:
Inclusion Criteria:

          -  Clinical presentation consistent with IPF with onset between three months and 48
             months prior to screening.

          -  Diagnosis made by high-resolution computed tomographic scan showing highly probable
             IPF.

          -  Absence of severe pulmonary hypertension (i.e., PAsys must be less than 55 mm Hg,
             based on echocardiography) and absence of decompensated right heart failure (NYHA
             class I or II acceptable).

          -  Age 40 through 80, inclusive.

          -  Abnormal pulmonary function tests (FVC 40-90% predicted or DLCO 30-90% predicted or
             impaired gas exchange with rest or exercise).

          -  Six-minute walk distance 150 m and 500 m.

          -  Worsening as demonstrated by any one of the following within the past year: > 10%
             decrease in percent predicted forced vital capacity or worsening dyspnea at rest or
             upon exertion, based on history.

          -  Ability to understand and sign a written informed consent form and comply with the
             requirements of the study.

          -  Absence of clinical features suggesting infection, neoplasm, sarcoidosis or
             collagen-vascular disease.

        Exclusion Criteria:

          -  Echocardiographic evidence of severe pulmonary hypertension (PAsys>55 mm Hg, based on
             echocardiography or TR velocity 3.2 m/sec).

          -  Severe heart failure (NYHA class III or IV or LVEF < 45%).

          -  Six-minute walk distance < 150 m or > 500 m.

          -  FEV1/FVC ratio < 0.7 at screening (post-bronchodilator).

          -  Residual volume > 100% predicted.

          -  Any condition other than IPF likely to result in the death of the participant within
             the next two years.

          -  History of unstable or deteriorating cardiac or neurologic disease.

          -  Pregnancy or lactation. Patients who are: (a) pregnant or (b) breast feeding are
             excluded from the study.

          -  Current treatment with corticosteroids (either oral or inhaled), Cytoxan,
             azathioprine, colchicine, pirfenidone, anti-tumor necrosis factor therapy or
             endothelin receptor blockers. Prior treatment is permitted, but at least four weeks of
             treatment washout prior to inclusion in this study are required.

          -  Investigational therapy for any indication within 28 days prior to enrollment.

          -  Degenerative arthritis, cerebrovascular accident or other limitation to mobility
             preventing completion of the 6-minute walk test.

          -  Oxygen saturation on room air <80% at rest.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 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? 1