Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600028
• Other study ID #: CG-0747
• Secondary ID: CG-0747
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2008
• Last updated: September 18, 2012
• Start date: December 2007
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Idiopathic Pulmonary Fibrosis (IPF) is a rapidly progressive lung disorder that is often associated with a chronic, intractable cough. The etiology of the cough associated with IPF is unclear but it is often so severe that it adversely effects the patient's quality of life. We propose that thalidomide specifically suppresses the cough associated with idiopathic pulmonary fibrosis via its anti-inflammatory properties, by suppressing the excessive functional up-regulation of sensory fibers with in the respiratory tract of patients with IPF.

This study is a Phase III, double blinded, randomized, placebo controlled, crossover trial testing the efficacy of thalidomide in suppressing the chronic cough of IPF. The primary objective of this study is to determine the efficacy of thalidomide administered daily for 12 weeks to suppress the chronic cough in patients with idiopathic pulmonary fibrosis as measured by cough specific questionnaires, scales and improved quality of life.

Description:

This study is a Phase III, double blinded, randomized, placebo controlled, crossover trial testing the efficacy of thalidomide in suppressing the chronic cough of IPF. All subjects will be randomized to either begin the study receiving the active study drug - (thalidomide) or inactive drug (placebo). Study drug will be administered in escalating dose starting at 50 mg a day increasing to 100 mg a day if cough is still present after 2 weeks. Study drug will be taken by mouth at bedtime. Patients will remain on their initial treatment for 12 weeks. After 12 weeks of treatment, the subjects will be administered the Cough Specific Quality of Life Questionnaire (CQLQ), a visual cough analogue scale, and St. Georges Respiratory Questionnaire (SGRQ). In addition, investigators will collect the subjects cough diary. After 12 weeks of treatment all subjects will enter a 2 week wash-out phase in which all drugs will be discontinued. After the 2 week wash-out phase, all subjects will again be administered the Cough Specific Quality of Life Questionnaire (CQLQ), a visual cough analogue scale, and St. Georges Respiratory Questionnaire (SGRQ). In addition, investigators will collect the subjects cough diary. All subjects will then be crossed over to the other treatment arm for an additional 12 weeks of treatment. After the second 12 weeks of treatment, the subjects will be administered the Cough Specific Quality of Life Questionnaire (CQLQ), a visual cough analogue scale, and St. Georges Respiratory Questionnaire (SGRQ). In addition, investigators will collect the subjects cough diary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Idiopathic pulmonary fibrosis for >3 months <5 years

• High resolution CT scan of chest consistent with IPF within the previous 12 months

• FVC > 40% and < 90% predicted, TLC >40% <80%, DLCo >30% <90%

• Chronic Cough - cough >8 weeks

• Age >50

• Non-child bearing potential

Exclusion Criteria:

• Pregnant or lactating women

• Women of child bearing potential

• Known etiology of lung fibrosis other than IPF

• Significant respiratory toxin exposure

• Collagen Vascular Disease

• Use of narcotic anti-cough agent in last week

• significant peripheral vascular disease or neuropathy

• history of seizures

• poorly controlled diabetes

• allergy to thalidomide

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cough
• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Thalidomide
thalidomide 50 - 100 mg by mouth daily
• Placebo
Placebo 50-100 mg by mouth per day

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of thalidomide in suppressing the chronic cough of idiopathic pulmonary fibrosis		6 month trial	No