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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Idiopathic Pulmonary Fibrosis
Cough
Interventions Drug: Thalidomide
Drug: Placebo
Enrollment 25
Recruitment Details Consecutive eligible patients were recruited by the investigators from their clinics and through self-referral between February 2008 and March 2011. 98 persons contacted our study coordinator with queries about the trial, 22 from the Johns Hopkins Interstitial Lung Disease Clinic and 76 in response to the ClinicalTrials.gov Web site.
Pre-assignment Details One participant was excluded because of an FVC>90% predicted
Arm/Group Title Drug Thalidomide First, Then Placebo Placebo First, Then Thalidomide Drug
Hide Arm/Group Description Drug Thalidomide 50-100mg daily in the first intervention period and placebo daily in the second intervention period (after washout period) Placebo was administered in the first interventional period and Thalidomide 50-100mg daily in the second interventional period (after washout period).
Period Title: First Intervention (12 Weeks)
Started 13 [1] 11 [1]
Completed 12 10
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             0
Adverse Event             0             1
[1]
Number of participants starting the first intervention (prior to washout)
Period Title: Second Intervention (12 Weeks)
Started 12 [1] 10 [1]
Completed 12 8
Not Completed 0 2
Reason Not Completed
Adverse Event             0             2
[1]
Number of participants starting the second intervention (after a 2-week washout)
Arm/Group Title Drug Thalidomide First, Then Placebo Placebo First, Then Thalidomide Drug Total
Hide Arm/Group Description Drug thalidomide 50 - 100 mg daily in the first intervention period and placebo daily in the second intervention period (after washout period) Placebo was administered in the first intervention period and Thalidomide 50 - 100 mg daily in the second intervention period(After washout period) Total of all reporting groups
Overall Number of Baseline Participants 13 11 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 11 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
13
 100.0%
11
 100.0%
24
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 11 participants 24 participants
70.5  (7.11) 65.55  (7.38) 67.8  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 11 participants 24 participants
Female
5
  38.5%
5
  45.5%
10
  41.7%
Male
8
  61.5%
6
  54.5%
14
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 11 participants 24 participants
13 11 24
1.Primary Outcome
Title Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Cough Quality of Life Questionnaire.
Hide Description

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).

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received the interventions and completed all study visits were included in the efficacy analysis.
Arm/Group Title Arm Thalidomide 1st, Placebo 2nd (Intervention Thalidomide) Arm Thalidomide 1st, Placebo 2nd (Intervention Placebo) Arm Placebo 1st, Thalidomide 2nd (Intervention Placebo) Arm Placebo 1st, Thalidomide 2nd (Intervention Thalidomide)
Hide Arm/Group Description:
Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the first intervention period
Intervention Placebo : Placebo 50-100 mg by mouth per day in the second intervention period
Intervention Placebo : Placebo 50 - 100 mg by mouth daily in the first intervention period
Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the second intervention period
Overall Number of Participants Analyzed 12 12 10 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
47.3  (13.7) 55.2  (14.4) 61.6  (11.9) 44.5  (12.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm Thalidomide 1st, Placebo 2nd (Intervention Thalidomide), Arm Thalidomide 1st, Placebo 2nd (Intervention Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4
Estimation Comments The values represents three months on each intervention
2.Secondary Outcome
Title 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.
Hide Description

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).

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received the interventions and completed all study visits were included in the efficacy analysis.
Arm/Group Title Arm Thalidomide 1st, Placebo 2nd (Intervention Thalidomide) Arm Thalidomide 1st, Placebo 2nd (Intervention Placebo) Arm Placebo 1st, Thalidomide 2nd (Intervention Placebo) Arm Placebo 1st, Thalidomide 2nd (Intervention Thalidomide)
Hide Arm/Group Description:
Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the first intervention period
Intervention Placebo : Placebo 50-100 mg by mouth per day in the second intervention period
Intervention Placebo : Placebo 50-100 mg by mouth per day in the first intervention period
Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the second intervention period
Overall Number of Participants Analyzed 12 12 10 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Severity of cough (VAS Score) 30.3  (28.5) 65.9  (23.3) 68  (26.8) 17.8  (9.9)
Quality of life (SGRQ Score) 46.4  (19.4) 54.7  (16.9) 58.8  (13.3) 40.7  (9.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm Thalidomide 1st, Placebo 2nd (Intervention Thalidomide), Arm Thalidomide 1st, Placebo 2nd (Intervention Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4
Estimation Comments The values represents three months on each intervention
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Thalidomide Placebo
Hide Arm/Group Description Thalidomide : thalidomide 50 - 100 mg by mouth daily Placebo : Placebo 50-100 mg by mouth per day
All-Cause Mortality
Thalidomide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Thalidomide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/23 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Thalidomide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/23 (34.78%)      1/23 (4.35%)    
Gastrointestinal disorders     
constipation *  8/23 (34.78%)  8 1/23 (4.35%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Maureen R. Horton
Organization: Johns Hopkins University School of Medicine
Phone: 410-955-4176
EMail: mhorton2@jhmi.edu
Layout table for additonal information
Responsible Party: Maureen R. Horton, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00600028    
Other Study ID Numbers: CG-0747
CG-0747 ( Other Grant/Funding Number: Celgene )
First Submitted: January 11, 2008
First Posted: January 24, 2008
Results First Submitted: April 4, 2013
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017