Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00287729
First received: February 6, 2006
Last updated: May 12, 2011
Last verified: May 2011
Results First Received: June 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
Interventions: Drug: Pirfenidone
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pirfenidone (2403 mg/d) pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
Placebo placebo equivalent, given as 3 divided doses 3 times/day

Participant Flow:   Overall Study
    Pirfenidone (2403 mg/d)     Placebo  
STARTED     171     173  
COMPLETED     137     142  
NOT COMPLETED     34     31  



  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
Pirfenidone (2403 mg/d) pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
Placebo placebo equivalent, given as 3 divided doses 3 times/day
Total Total of all reporting groups

Baseline Measures
    Pirfenidone (2403 mg/d)     Placebo     Total  
Number of Participants  
[units: participants]
  171     173     344  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     70     61     131  
>=65 years     101     112     213  
Age  
[units: years]
Mean ± Standard Deviation
  66.8  ± 7.90     67.0  ± 7.80     66.9  ± 7.84  
Gender  
[units: participants]
     
Female     48     49     97  
Male     123     124     247  
Region of Enrollment  
[units: participants]
     
United States     148     150     298  
Europe     23     22     45  
Australia     0     1     1  



  Outcome Measures
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1.  Primary:   Absolute Change in Percent Predicted Forced Vital Capacity(FVC)   [ Time Frame: Baseline to week 72 ]

2.  Secondary:   Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity   [ Time Frame: Baseline to week 72 ]

3.  Secondary:   Progression-free Survival   [ Time Frame: Baseline to Week 72 ]

4.  Secondary:   Change in the Six-Minute Walk Test (6MWT) Distance   [ Time Frame: Baseline to Week 72 ]

5.  Secondary:   Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test   [ Time Frame: Baseline to Week 72 ]

6.  Secondary:   Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs   [ Time Frame: Baseline to Week 72 ]

7.  Secondary:   Change in Dyspnea Score   [ Time Frame: Baseline to Week 72 ]

8.  Secondary:   Worsening of IPF   [ Time Frame: Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first. ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Bill Bradford, MD, PhD
Organization: InterMune, Inc.
phone: (415) 466-2200
e-mail: bbradford@intermune.com


No publications provided by InterMune

Publications automatically indexed to this study:

Responsible Party: Bill Bradford, MD PhD/ Vice President, InterMune, Inc.
ClinicalTrials.gov Identifier: NCT00287729     History of Changes
Other Study ID Numbers: PIPF-006, Capacity 1
Study First Received: February 6, 2006
Results First Received: June 2, 2010
Last Updated: May 12, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
United States: Food and Drug Administration