CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 25 enrolled
Drug / intervention
Thalidomide +1 moredrug
Likely dose
Thalidomide 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00600028
NCT00600028Phase 3Completed

Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide

Johns Hopkins University·interventional·Posted Jan 24, 2008·Updated May 15, 2017

In Brief

A Phase 3 clinical trial evaluating Thalidomide and Placebo for Idiopathic Pulmonary Fibrosis and Cough. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 24, 2008
Enrollment StartDec 1, 2007
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.4 years ago

Interventions

Thalidomidedrug

Thalidomide 50 - 100 mg by mouth daily

Placebodrug

Placebo 50-100 mg by mouth per day