Clinical trial: Pomalidomide for Cough in Patients With Idiopathic Pulmonary Fibrosis (NCT01135199)

Eligibility criteria:
Inclusion Criteria:

          1. Understand and voluntarily sign an informed consent form.

          2. >18 and < 75 years old at the time of signing the informed consent form.

          3. Able to adhere to the study visit schedule and other protocol requirements.

          4. Have a diagnosis of Idiopathic Pulmonary Fibrosis in accordance to American Thoracic
             Society guidelines.

          5. Persistent cough:

             • as defined by a cough that adversely affects the patient's quality of life and has
             been present for at least 3 months.

          6. Laboratory test results within these ranges:

               -  Absolute neutrophil count >2 x 103/ul

               -  Platelet count >100,000 /mm³

               -  Serum creatinine < 2.0 mg/dL

               -  Total bilirubin < 1.5 mg/dL

          7. Diffusion capacity > 25%predicted

          8. Forced vital capacity <80% predicted • AST (SGOT) and ALT (SGPT) < 2 x ULN

        8. Able to take aspirin (81 or 325 mg) daily as prophylactic anti-coagulation (patients
        intolerant to ASA may use warfarin or low molecular weight heparin).

        Exclusion Criteria:

          1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          2. Females of child-bearing potential defined as a sexually mature woman who: 1) has not
             undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
             postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in
             the preceding 24 consecutive months).

          3. Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study.

          4. Use of any other experimental drug or therapy within 28 days of baseline.

          5. Known hypersensitivity to thalidomide or lenalidomide.

          6. Any prior use of thalidomide, lenalidomide or pomalidomide (CC-4047).

          7. Known positive for HIV or infectious hepatitis, type A, B or C.

          8. History of deep venous thrombosis

          9. History of pulmonary embolism

         10. Use of the following anti-tussive agents must be discontinued 14 days prior to their
             baseline visit. -

        1. prednisone 2. narcotic anti-tussives 3. baclofen 4. neurontin 11. Treatment for
        infection or acute exacerbation within past 3 months
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