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Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)

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ClinicalTrials.gov Identifier: NCT02598193
Recruitment Status : Completed
First Posted : November 5, 2015
Results First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Drug: Nintedanib
Drug: Pirfenidone
Enrollment 89
Recruitment Details Participants with idiopathic pulmonary fibrosis were recruited for this study.
Pre-assignment Details At the start of screening, participants were on pirfenidone for at least 16 weeks and on a stable dose (1602–2403 mg/d) for at least 28 days. A total of 109 participants were screened, 20 participants were screen failures and 89 were enrolled at 36 study centers in 8 countries.
Arm/Group Title Pirfenidone+Nintedanib
Hide Arm/Group Description Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
Period Title: Overall Study
Started 89
Completed 73
Not Completed 16
Reason Not Completed
Adverse Event             13
Withdrawal by Subject             1
Listed in active lung transplant list             1
Does not want to take Nintedanib             1
Arm/Group Title Pirfenidone+Nintedanib
Hide Arm/Group Description Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
Overall Number of Baseline Participants 89
Hide Baseline Analysis Population Description
Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants
68.2  (6.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Female
18
  20.2%
Male
71
  79.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Hispanic or Latino
9
  10.1%
Not Hispanic or Latino
74
  83.1%
Unknown or Not Reported
6
   6.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 89 participants
White 84
Black or African American 3
Asian 1
Asian/White 1
1.Primary Outcome
Title Percentage of Participants Who Complete 24 Weeks of Combination Treatment on Pirfenidone at a Dose of 1602-2403 mg/Day and Nintedanib at a Dose of 200-300 mg/Day
Hide Description [Not Specified]
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.
Arm/Group Title Pirfenidone+Nintedanib
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
Overall Number of Participants Analyzed 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
77.5
(67.4 to 85.7)
2.Secondary Outcome
Title Percentage of Participants With Adverse Events and Serious Adverse Events
Hide Description An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame Baseline up to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.
Arm/Group Title Pirfenidone+Nintedanib
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
Overall Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: Percentage of Participants
Adverse Event 98.9
Serious Adverse Event 18.0
3.Secondary Outcome
Title Percentage of Participants Who Discontinue Pirfenidone, Nintedanib, or Both Study Treatments Because of Adverse Events Before the Week 24 Visit
Hide Description [Not Specified]
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.
Arm/Group Title Pirfenidone+Nintedanib
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Praticipants
14.6
(8.0 to 23.7)
4.Secondary Outcome
Title Total Number of Participant Days of Combination Treatment With Pirfenidone and Nintedanib
Hide Description [Not Specified]
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.
Arm/Group Title Pirfenidone+Nintedanib
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
Overall Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: Participant Days
13330
5.Secondary Outcome
Title Total Number of Days From the Initiation of Combination Treatment to Discontinuation of Pirfenidone, Nintedanib, or Both Study Treatments
Hide Description [Not Specified]
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.
Arm/Group Title Pirfenidone+Nintedanib
Hide Arm/Group Description:
Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: Number of Days
149.8  (43.93)
Time Frame Baseline up to Week 28
Adverse Event Reporting Description Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.
 
Arm/Group Title Pirfenidone+Nintedanib
Hide Arm/Group Description Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks.
All-Cause Mortality
Pirfenidone+Nintedanib
Affected / at Risk (%)
Total   0/89 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Pirfenidone+Nintedanib
Affected / at Risk (%) # Events
Total   16/89 (17.98%)    
Gastrointestinal disorders   
Pancreatitis * 1  1/89 (1.12%)  1
Hepatobiliary disorders   
Cholelithiasis * 1  1/89 (1.12%)  1
Infections and infestations   
Cholecystitis infective * 1  1/89 (1.12%)  1
Influenza * 1  1/89 (1.12%)  1
Pneumonia * 1  1/89 (1.12%)  1
Tracheobronchitis * 1  1/89 (1.12%)  1
Injury, poisoning and procedural complications   
Concussion * 1  1/89 (1.12%)  1
Musculoskeletal and connective tissue disorders   
Lumbar spinal stenosis * 1  1/89 (1.12%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Invasive ductal breast carcinoma * 1  1/89 (1.12%)  1
Prostate cancer * 1  1/89 (1.12%)  1
Nervous system disorders   
Transient ischaemic attack * 1  1/89 (1.12%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax * 1  3/89 (3.37%)  3
Idiopathic pulmonary fibrosis * 1  2/89 (2.25%)  2
Pneumomediastinum * 1  1/89 (1.12%)  1
Vascular disorders   
Deep vein thrombosis * 1  1/89 (1.12%)  1
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pirfenidone+Nintedanib
Affected / at Risk (%) # Events
Total   83/89 (93.26%)    
Gastrointestinal disorders   
Diarrhoea * 1  52/89 (58.43%)  184
Nausea * 1  44/89 (49.44%)  70
Vomiting * 1  29/89 (32.58%)  57
Dyspepsia * 1  8/89 (8.99%)  8
Gastrooesophageal reflux disease * 1  7/89 (7.87%)  7
Abdominal pain upper * 1  6/89 (6.74%)  7
General disorders   
Fatigue * 1  14/89 (15.73%)  16
Non-cardiac chest pain * 1  5/89 (5.62%)  6
Infections and infestations   
Viral upper respiratory tract infection * 1  9/89 (10.11%)  13
Upper respiratory tract infection * 1  8/89 (8.99%)  9
Investigations   
Weight decreased * 1  6/89 (6.74%)  6
Metabolism and nutrition disorders   
Decreased appetite * 1  14/89 (15.73%)  14
Nervous system disorders   
Headache * 1  13/89 (14.61%)  22
Dizziness * 1  9/89 (10.11%)  9
Respiratory, thoracic and mediastinal disorders   
Cough * 1  20/89 (22.47%)  22
Dyspnoea * 1  10/89 (11.24%)  10
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02598193     History of Changes
Other Study ID Numbers: MA29895
2015-003280-11 ( EudraCT Number )
First Submitted: November 4, 2015
First Posted: November 5, 2015
Results First Submitted: May 16, 2018
Results First Posted: June 13, 2018
Last Update Posted: June 13, 2018