Phase 3
N=24
Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide
Idiopathic Pulmonary Fibrosis · Cough
Bottom Line
View on ClinicalTrials.gov: NCT00600028 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Cough Quality of Life Questionnaire. — 47.3; 55.2; 61.6; 44.5 units on a scale — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Thalidomide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Cough Quality of Life Questionnaire. |
47.3; 55.2; 61.6; 44.5 | 0.001 sig |
| SECONDARY Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Visual Analog Scale of Cough and the St. George Respiratory Questionnaire. |
30.3; 65.9; 68; 17.8; 46.4; 54.7 | .0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Idiopathic pulmonary fibrosis for >3 months 40% and 40% 30% 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
Data sourced from ClinicalTrials.gov (NCT00600028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.