This clinical study will evaluate the safety and tolerability of combination treatment of nintedanib and pirfenidone in participants with IPF. Eligible participants must have received pirfenidone for at least 16 weeks on a stable dose. Nintedanib will be added on Day 1 of the study as a combination treatment for IPF for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Participants with IPF will receive nintedanib at the 200-300 mg/day dose up to 24 weeks.
Participants with IPF will receive pirfenidone at 1602-2403 mg/day dose up to 24 weeks.
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
Time frame: Week 24
Percentage of Participants With Adverse Events and Serious Adverse Events
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
Percentage of Participants Who Discontinue Pirfenidone, Nintedanib, or Both Study Treatments Because of Adverse Events Before the Week 24 Visit
Time frame: Baseline up to Week 24
Total Number of Participant Days of Combination Treatment With Pirfenidone and Nintedanib
Time frame: Baseline up to Week 24
Total Number of Days From the Initiation of Combination Treatment to Discontinuation of Pirfenidone, Nintedanib, or Both Study Treatments
Time frame: Baseline up to Week 24
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David Geffen School of Medicine at UCLA;Division of Pulmonary & Critical Care/ Department of Medic
Los Angeles, California, United States
Stanford University School of Medicine ; Pulmonary/Critical Care Medicine
Stanford, California, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Cardio-Pulmonary Associates of St. Luke's Hospital
Chesterfield, Missouri, United States
Creighton University
Omaha, Nebraska, United States
Atlantic Respiratory Institute
Summit, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
...and 28 more locations