Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide

NCT00600028 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CG-0747
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis; Cough

Keywords

idiopathic pulmonary fibrosis cough

Outcome Measures

Primary Outcomes (1)

• Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Cough Quality of Life Questionnaire.

  The primary endpoint, suppression of cough was measured by the Cough Quality of Life Questionnaire (CQLQ) to measure the effect of interventions on cough-specific quality of life. CQLQ consist of 28 questions about cough and its effects using Likert-like 4-point scales, with lower scores indicating less effect of cough on health related quality of life. CQLQ scale ranges from 28 to 112 ( The lower the value, the higher the quality of life, 28 is considered the best).

  6 months

Secondary Outcomes (1)

• 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.

  6 months

Study Arms (2)

Experimental: Thalidomide, then placebo

EXPERIMENTAL

Participants first received Thalidomide tablet for 12 weeks. After a washout period of two weeks, they then received placebo tablet for 12 weeks.

Drug: Thalidomide; Drug: Placebo

Experimental: Placebo, then Thalidomide

EXPERIMENTAL

Participants first received Placebo tablet for 12 weeks. After a washout period of two weeks, they then received Thalidomide tablet for 12 weeks.

Drug: Thalidomide; Drug: Placebo

Interventions

Thalidomide DRUG

Thalidomide 50 - 100 mg by mouth daily

Experimental: Placebo, then Thalidomide; Experimental: Thalidomide, then placebo

Placebo DRUG

Placebo 50-100 mg by mouth per day

Experimental: Placebo, then Thalidomide; Experimental: Thalidomide, then placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Horton MR, Santopietro V, Mathew L, Horton KM, Polito AJ, Liu MC, Danoff SK, Lechtzin N. Thalidomide for the treatment of cough in idiopathic pulmonary fibrosis: a randomized trial. Ann Intern Med. 2012 Sep 18;157(6):398-406. doi: 10.7326/0003-4819-157-6-201209180-00003.

  PMID: 22986377 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Cough

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Maureen R. Horton
• Organization: Johns Hopkins University School of Medicine

mhorton2@jhmi.edu

410-955-4176

Study Officials

• Maureen Horton, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 24, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)