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

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.
ClinicalTrials.gov Identifier: NCT00650091
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : June 2, 2015
Last Update Posted : June 2, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pulmonary Fibrosis
Interventions: Drug: N-acetylcysteine (NAC)
Drug: Placebo

  Participant Flow

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

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
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 
Overall Participants Analyzed 
[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

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

Time Frame Adverse events are reported for amended study only.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Initial Study: Pred/AZA/NAC Participants will receive prednisone, azathioprine, and N-acetylcysteine (NAC) for 60 weeks.
Initial Study: Placebo Placebo: Participants will receive placebo each day.

Other Adverse Events
    N-Acetylcysteine   Placebo   Initial Study: Pred/AZA/NAC   Initial Study: Placebo
Total, Other (not including serious) Adverse Events         
# participants affected / at risk   123/133 (92.48%)   117/131 (89.31%)   68/77 (88.31%)   61/78 (78.21%) 
Gastrointestinal disorders         
Diarrhoea †         
# participants affected / at risk   18/133 (13.53%)   15/131 (11.45%)   6/77 (7.79%)   7/78 (8.97%) 
# events   19   18   7   8 
Nausea †         
# participants affected / at risk   14/133 (10.53%)   7/131 (5.34%)   10/77 (12.99%)   4/78 (5.13%) 
# events   14   9   14   4 
Constipation †         
# participants affected / at risk   12/133 (9.02%)   4/131 (3.05%)   2/77 (2.60%)   4/78 (5.13%) 
# events   13   4   2   4 
General disorders         
Fatigue †         
# participants affected / at risk   9/133 (6.77%)   9/131 (6.87%)   8/77 (10.39%)   6/78 (7.69%) 
# events   9   9   9   6 
Oedema peripheral †         
# participants affected / at risk   9/133 (6.77%)   6/131 (4.58%)   2/77 (2.60%)   3/78 (3.85%) 
# events   11   6   3   3 
Infections and infestations         
Upper respiratory tract infection †         
# participants affected / at risk   27/133 (20.30%)   26/131 (19.85%)   10/77 (12.99%)   10/78 (12.82%) 
# events   31   31   11   11 
Bronchitis †         
# participants affected / at risk   15/133 (11.28%)   13/131 (9.92%)   6/77 (7.79%)   6/78 (7.69%) 
# events   26   15   6   8 
Sinusitis †         
# participants affected / at risk   17/133 (12.78%)   10/131 (7.63%)   4/77 (5.19%)   5/78 (6.41%) 
# events   22   12   6   5 
Nasopharyngitis †         
# participants affected / at risk   10/133 (7.52%)   11/131 (8.40%)   4/77 (5.19%)   7/78 (8.97%) 
# events   13   15   6   10 
Musculoskeletal and connective tissue disorders         
Arthralgia †         
# participants affected / at risk   10/133 (7.52%)   10/131 (7.63%)   2/77 (2.60%)   5/78 (6.41%) 
# events   10   13   2   8 
Nervous system disorders         
Headache †         
# participants affected / at risk   12/133 (9.02%)   12/131 (9.16%)   3/77 (3.90%)   3/78 (3.85%) 
# events   14   12   3   3 
Dizziness †         
# participants affected / at risk   8/133 (6.02%)   8/131 (6.11%)   5/77 (6.49%)   6/78 (7.69%) 
# events   9   10   7   8 
Respiratory, thoracic and mediastinal disorders         
Cough †         
# participants affected / at risk   37/133 (27.82%)   32/131 (24.43%)   13/77 (16.88%)   18/78 (23.08%) 
# events   44   39   15   20 
Dyspnea †         
# participants affected / at risk   22/133 (16.54%)   26/131 (19.85%)   11/77 (14.29%)   10/78 (12.82%) 
# events   25   29   12   11 
Idiopathic Pulmonary Fibrosis †         
# participants affected / at risk   12/133 (9.02%)   8/131 (6.11%)   9/77 (11.69%)   4/78 (5.13%) 
# events   14   10   12   5 
Epistaxis †         
# participants affected / at risk   6/133 (4.51%)   11/131 (8.40%)   1/77 (1.30%)   5/78 (6.41%) 
# events   6   12   1   5 
Events were collected by systematic assessment



  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.


  More Information

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


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: Pro00020066
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