Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF (PANTHER-IPF)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00650091
First received: March 28, 2008
Last updated: May 27, 2015
Last verified: February 2015
Results First Received: July 31, 2014  
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: Pulmonary Fibrosis
Interventions: Drug: N-acetylcysteine (NAC)
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

Initial Study Design: Subjects are randomly assigned to receive a three-drug regimen of prednisone, azathioprine, and acetylcysteine; acetylcysteine alone; or placebo.

Amended Study Design: The three-drug regimen was removed from the protocol due to safety concerns on 10/14/2011. Subjects are randomly assigned to acetylcysteine or placebo.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants in the Pred/AZA/NAC group were discontinued and not re-randomized in the amended study.

Reporting Groups
  Description
N-Acetylcysteine

Participants will receive N-acetylcysteine (NAC) for 60 weeks.

N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.

Placebo

Participants will receive placebo for 60 weeks.

Placebo: Participants will receive placebo each day.

Pred/AZA/NAC

The prednisone dose was started at 0.5 mg per kilo- gram of ideal body weight and was tapered to 0.15 mg per kilogram during a period of 25 weeks.

The azathioprine dose (maximum, 150 mg per day) was based on the patient’s ideal weight, concurrent use of allopurinol, and thiopurine methyl-transferase (TPMT) activity. NAC was prescribed at 600 mg orally three times a day.


Participant Flow for 2 periods

Period 1:   Initial Study Design - Interim Analysis
    N-Acetylcysteine     Placebo     Pred/AZA/NAC  
STARTED     81     78     77  
COMPLETED     81     78     77  
NOT COMPLETED     0     0     0  

Period 2:   Amended Study Design
    N-Acetylcysteine     Placebo     Pred/AZA/NAC  
STARTED     133     131     0 [1]
COMPLETED     110     111     0  
NOT COMPLETED     23     20     0  
Withdrawal by Subject                 12                 11                 0  
Physician Decision                 5                 0                 0  
Adverse Event                 1                 4                 0  
Lung transplantation                 4                 2                 0  
Not specified                 1                 3                 0  
[1] Study Drug was discontinued for all subjects due to safety concerns.



  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.
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Reporting Groups
  Description
N-Acetylcysteine

Participants will receive N-acetylcysteine (NAC) for 60 weeks.

N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.

Placebo

Participants will receive placebo for 60 weeks.

Placebo: Participants will receive placebo each day.

Total Total of all reporting groups

Baseline Measures
    N-Acetylcysteine     Placebo     Total  
Number of Participants  
[units: participants]
  133     131     264  
Age  
[units: years]
Mean (Standard Deviation)
  68.3  (6.4)     67.2  (8.2)     67.8  (8.3)  
Gender  
[units: participants]
     
Female     26     33     59  
Male     107     98     205  



  Outcome Measures
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1.  Primary:   Overall Change in Forced Vital Capacity   [ Time Frame: Measured as the estimated change from baseline to Week 60 ]

2.  Secondary:   Disease Progression   [ Time Frame: Measured at Week 60 ]

3.  Secondary:   Acute Exacerbations   [ Time Frame: Measured at Week 60 ]

4.  Secondary:   Respiratory Infections   [ Time Frame: Measured at Week 60 ]

5.  Secondary:   Number of Participants With Maintained Forced Vital Capacity Response   [ Time Frame: Measured at Week 60 ]

6.  Post-Hoc:   Change in Forced Vital Capacity   [ Time Frame: Baseline, 15, 30, 45, 60 week ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Kevin J Anstrom
Organization: Duke Clinical Research Institute
phone: 919-668-8902
e-mail: kevin.anstrom@duke.edu


No publications provided by Duke University

Publications automatically indexed to this study:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00650091     History of Changes
Other Study ID Numbers: Pro00020066, U10HL080413-03
Study First Received: March 28, 2008
Results First Received: July 31, 2014
Last Updated: May 27, 2015
Health Authority: United States: Food and Drug Administration