Pomalidomide for Cough in Patients With Idiopathic Pulmonary Fibrosis

NCT01135199 | Withdrawn Phase 2

• 1 other identifier: SU-05302008-1189
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Outcome Measure: Cough related QOL as measured by Cough-Specific Quality of LIfe instrument (CQLQ)

  12 weeks

Secondary Outcomes (1)

• Outcome Measure: Cough severity as measured by Leicester Cough Questionnaire (LCQ), Visual Analog Scale (VAS), St. George Respiratory Questionnaire (SGRQ)

  12 wks

Study Arms (1)

Treatment

OTHER

Open label

Drug: pomalidomide (CC-4047

Interventions

pomalidomide (CC-4047 DRUG

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. 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).

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Celgene Corporation: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Horton MR, Danoff SK, Lechtzin N. Thalidomide inhibits the intractable cough of idiopathic pulmonary fibrosis. Thorax. 2008 Aug;63(8):749. doi: 10.1136/thx.2008.098699. No abstract available.

  PMID: 18663075 BACKGROUND

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

pomalidomide

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Glenn D. Rosen

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 2, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

US (1)