Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF (PANTHER-IPF)
|Study Design:||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
Drug: N-acetylcysteine (NAC)
|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.
|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.|
Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.
Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day.
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
Period 2: Amended Study Design
|Withdrawal by Subject||12||11||0|
|||Study Drug was discontinued for all subjects due to safety concerns.|
|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 ]|
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.|
|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:
Organization: Duke Clinical Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Duke University|
|ClinicalTrials.gov Identifier:||NCT00650091 History of Changes|
|Other Study ID Numbers:||
U10HL080413-03 ( U.S. NIH Grant/Contract )
|First Submitted:||March 28, 2008|
|First Posted:||April 1, 2008|
|Results First Submitted:||July 31, 2014|
|Results First Posted:||June 2, 2015|
|Last Update Posted:||June 2, 2015|