Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maureen R. Horton, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00600028
First received: January 11, 2008
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Cough
Drug: Thalidomide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Efficacy of thalidomide in suppressing the chronic cough of idiopathic pulmonary fibrosis [ Time Frame: 6 month trial ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: December 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Thalidomide
thalidomide 50 - 100 mg by mouth daily
Placebo Comparator: 2 Drug: Placebo
Placebo 50-100 mg by mouth per day

Detailed 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600028

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Maureen Horton, MD Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maureen R. Horton, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00600028     History of Changes
Other Study ID Numbers: CG-0747, CG-0747
Study First Received: January 11, 2008
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
idiopathic pulmonary fibrosis cough

Additional relevant MeSH terms:
Fibrosis
Cough
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014