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Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00600028
First Posted: January 24, 2008
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maureen R. Horton, Johns Hopkins University
Results First Submitted: April 4, 2013  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant was excluded because of an FVC>90% predicted

Reporting Groups
  Description
Drug Thalidomide First, Then Placebo Drug Thalidomide 50-100mg daily in the first intervention period and placebo daily in the second intervention period (after washout period)
Placebo First, Then Thalidomide Drug Placebo was administered in the first interventional period and Thalidomide 50-100mg daily in the second interventional period (after washout period).

Participant Flow for 2 periods

Period 1:   First Intervention (12 Weeks)
    Drug Thalidomide First, Then Placebo   Placebo First, Then Thalidomide Drug
STARTED   13 [1]   11 [1] 
COMPLETED   12   10 
NOT COMPLETED   1   1 
Withdrawal by Subject                1                0 
Adverse Event                0                1 
[1] Number of participants starting the first intervention (prior to washout)

Period 2:   Second Intervention (12 Weeks)
    Drug Thalidomide First, Then Placebo   Placebo First, Then Thalidomide Drug
STARTED   12 [1]   10 [1] 
COMPLETED   12   8 
NOT COMPLETED   0   2 
Adverse Event                0                2 
[1] Number of participants starting the second intervention (after a 2-week washout)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Drug Thalidomide First, Then Placebo Drug thalidomide 50 - 100 mg daily in the first intervention period and placebo daily in the second intervention period (after washout period)
Placebo First, Then Thalidomide Drug Placebo was administered in the first intervention period and Thalidomide 50 - 100 mg daily in the second intervention period(After washout period)
Total Total of all reporting groups

Baseline Measures
   Drug Thalidomide First, Then Placebo   Placebo First, Then Thalidomide Drug   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   11   24 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 70.5  (7.11)   65.55  (7.38)   67.8  (7.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  38.5%      5  45.5%      10  41.7% 
Male      8  61.5%      6  54.5%      14  58.3% 
Region of Enrollment 
[Units: Participants]
     
United States   13   11   24 


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

2.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Maureen R. Horton
Organization: Johns Hopkins University School of Medicine
phone: 410-955-4176
e-mail: mhorton2@jhmi.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Maureen R. Horton, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00600028     History of Changes
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