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Trial record 1 of 1 for:    NCT00600028
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Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide

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ClinicalTrials.gov Identifier: NCT00600028
Recruitment Status : Completed
First Posted : January 24, 2008
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Maureen R. Horton, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE January 11, 2008
First Posted Date  ICMJE January 24, 2008
Results First Submitted Date  ICMJE April 4, 2013
Results First Posted Date  ICMJE May 15, 2017
Last Update Posted Date May 15, 2017
Study Start Date  ICMJE December 2007
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2008)
Efficacy of thalidomide in suppressing the chronic cough of idiopathic pulmonary fibrosis [ Time Frame: 6 month trial ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
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).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide
Official Title  ICMJE Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Idiopathic Pulmonary Fibrosis
  • Cough
Intervention  ICMJE
  • Drug: Thalidomide
    Thalidomide 50 - 100 mg by mouth daily
  • Drug: Placebo
    Placebo 50-100 mg by mouth per day
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Thalidomide
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Thalidomide
    • Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2012)
25
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2008)
20
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00600028
Other Study ID Numbers  ICMJE CG-0747
CG-0747 ( Other Grant/Funding Number: Celgene )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maureen R. Horton, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maureen Horton, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP