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Pomalidomide for Cough in Patients With Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01135199
Recruitment Status : Withdrawn (The FDA did not accept the sponsor's additional animal toxicology data to support the proposed dosing in this protocol.)
First Posted : June 2, 2010
Last Update Posted : April 8, 2015
Celgene Corporation
Information provided by:
Stanford University

Brief Summary:
The purpose of this study is to determine the safety and efficacy of pomalidomide over a 12 week duration in the treatment of chronic cough in patients with IPF as measured by a Cough Symptom Diary, Visual Analogue Scale for Cough Severity, Leicester Cough Questionnaire, St. George Respiratory Questionnaire, Cough-Specific Quality-of-Life Questionnaire, and adverse event reporting. There will be an option open to participants, who respond to treatment by meeting pre-determined criteria, to remain in the study for an additional 9 months or for a total of 54 weeks.

Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Drug: pomalidomide (CC-4047 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Pomalidomide in the Treatment of Refractory Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): A Pilot Study

Primary Outcome Measures :
  1. Outcome Measure: Cough related QOL as measured by Cough-Specific Quality of LIfe instrument (CQLQ) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Outcome Measure: Cough severity as measured by Leicester Cough Questionnaire (LCQ), Visual Analog Scale (VAS), St. George Respiratory Questionnaire (SGRQ) [ Time Frame: 12 wks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01135199

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Celgene Corporation
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Principal Investigator: Glenn D. Rosen Stanford University
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Responsible Party: Glenn D. Rosen, Stanford University School of Medicine Identifier: NCT01135199    
Other Study ID Numbers: SU-05302008-1189
Protocol # 15447
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents