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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: April 6, 2017
Last verified: April 2017
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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 Maureen R. Horton, Johns Hopkins University:

Primary Outcome Measures:
  • Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Cough Quality of Life Questionnaire. [ Time Frame: 6 months ]

    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).



Secondary Outcome Measures:
  • 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. [ Time Frame: 6 months ]

    The secondary endpoint, suppression of cough was measured by the visual analog scale of cough (VAS) was significantly lower during treatment with thalidomide than placebo.

    Secondary endpoints were Cough VAS - the visual analog scale of cough evaluates the severity of cough in patients with IPF.

    Visual analog scale of cough ranges from 0 to 100 (0 is considered the best).

    St. George Respiratory Questionnaire helps to evaluate cough-specific and respiratory quality of life in patients with IPF.

    St. George Respiratory Questionnaire score ranges from 0 to 100 (0 is considered the best).



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: Experimental: Thalidomide, then placebo
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
Thalidomide 50 - 100 mg by mouth daily
Drug: Placebo
Placebo 50-100 mg by mouth per day
Experimental: Experimental: Placebo, then Thalidomide
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
Thalidomide 50 - 100 mg by mouth daily
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   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ( Other Grant/Funding Number: Celgene )
Study First Received: January 11, 2008
Results First Received: April 4, 2013
Last Updated: April 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maureen R. Horton, Johns Hopkins University:
idiopathic pulmonary fibrosis cough

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

ClinicalTrials.gov processed this record on September 21, 2017