Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide

April 6, 2017 updated by: Maureen R. Horton, Johns Hopkins University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Maureen Horton, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (ESTIMATE)

January 24, 2008

Study Record Updates

Last Update Posted (ACTUAL)

May 15, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CG-0747 (OTHER_GRANT: Celgene)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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