Pomalidomide for Cough in Patients With Idiopathic Pulmonary Fibrosis - Full Text View

Purpose

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	Intervention	Phase
Pulmonary Fibrosis	Drug: pomalidomide (CC-4047	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: idiopathic pulmonary fibrosis

MedlinePlus related topics: Cough Pulmonary Fibrosis

Drug Information available for: Pomalidomide

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Outcome Measure: Cough related QOL as measured by Cough-Specific Quality of LIfe instrument (CQLQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	July 2010
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Understand and voluntarily sign an informed consent form.
>18 and < 75 years old at the time of signing the informed consent form.
Able to adhere to the study visit schedule and other protocol requirements.
Have a diagnosis of Idiopathic Pulmonary Fibrosis in accordance to American Thoracic Society guidelines.
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.
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
Diffusion capacity > 25%predicted
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:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
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).
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.
Use of any other experimental drug or therapy within 28 days of baseline.
Known hypersensitivity to thalidomide or lenalidomide.
Any prior use of thalidomide, lenalidomide or pomalidomide (CC-4047).
Known positive for HIV or infectious hepatitis, type A, B or C.
History of deep venous thrombosis
History of pulmonary embolism
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135199

Contacts

Contact: Susan S Jacobs, RN, MS

(650) 725-8082

ssjpulm@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Not yet recruiting
Stanford, California, United States, 94305
Contact: Susan S Jacobs, RN, MS 650-725-8082 ssjpulm@stanford.edu
Principal Investigator: Glenn D. Rosen
Sub-Investigator: Paul K Mohabir
Sub-Investigator: Julie Olsson

Sponsors and Collaborators

Stanford University

Celgene Corporation

Investigators

Principal Investigator:

Glenn D. Rosen

Stanford University

More Information

Publications:

Horton MR, Danoff SK, Lechtzin N. Thalidomide inhibits the intractable cough of idiopathic pulmonary fibrosis. Thorax. 2008 Aug;63(8):749. No abstract available.

Responsible Party:	Glenn D. Rosen, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT01135199 History of Changes
Other Study ID Numbers:	SU-05302008-1189, Protocol # 15447
Study First Received:	May 28, 2010
Last Updated:	May 28, 2010
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Additional relevant MeSH terms:

Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Thalidomide
Immunosuppressive Agents
Immunologic Factors

Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013