drugset / Trial / NCT00600028

Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide

NCT00600028

Phase 3 Completed 25 enrolled Johns Hopkins University
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2007-12
Primary completion
2011-09
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Thalidomide Other / unclassified 100 mg Oral