Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Registration Number
- NCT02579603
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is a phase IV, twelve week, open label, randomized, parallel group study to assess safety and tolerability of combined treatment with nintedanib and pirfenidone.
A secondary objective is to assess the exposure based on PK trough concentration values to nintedanib either given alone or in combination with pirfenidone and to assess the exposure of pirfenidone when combined with nintedanib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nintedanib Nintedanib Nintedanib 150 mg bid Nintedanib and Pirfenidone Nintedanib Nintedanib 150 mg bid combined with pirfenidone up to 801 mg tid Nintedanib and Pirfenidone Pirfenidone Nintedanib 150 mg bid combined with pirfenidone up to 801 mg tid
- Primary Outcome Measures
Name Time Method Percentage of Patients With On-treatment Gastrointestinal (GI) AEs (SOC GI Disorders) From Baseline to Week 12 Baseline to week 12 Percentage of patients with on-treatment gastrointestinal (GI) Adverse events (AEs) (SOC GI disorders) from baseline to week 12.
On-treatment AEs were defined as AEs with an onset from the first dose of randomised treatment up to the last dose of randomised treatment (inclusive).
- Secondary Outcome Measures
Name Time Method Predose Plasma Concentrations at Steady State (Cpre,ss) of Nintedanib at Baseline, Weeks 2 and 4 baseline, prior to intake of study medication on week 2 and week 4 Predose plasma concentrations at steady state (Cpre,ss) of nintedanib at baseline (Visit 3), Week 2 (Visit 4) and Week 4 (Visit 5)
Predose Plasma Concentrations at Steady State (Cpre,ss) of Pirfenidone Prior to intake of study medication on week 2 and week 4 Predose plasma concentrations at steady state (Cpre,ss) of pirfenidone at Week 2 (Visit 4) and Week 4 (Visit 5)
Trial Locations
- Locations (23)
Western CT Medical Group, P.C.
🇺🇸Danbury, Connecticut, United States
Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Minnesota Lung Center
🇺🇸Minneapolis, Minnesota, United States
The Lung Research Center, LLC
🇺🇸Chesterfield, Missouri, United States
Lowcountry Lung and Crit Care
🇺🇸Charleston, South Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Concordia Hospital
🇨🇦Winnipeg, Manitoba, Canada
HOP Avicenne
🇫🇷Bobigny, France
HOP de la Cavale Blanche
🇫🇷Brest, France
Scroll for more (13 remaining)Western CT Medical Group, P.C.🇺🇸Danbury, Connecticut, United States