Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Public ClinicalTrials.gov record NCT02598193. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Exploratory Multicenter, Open-Label, Single Arm Study of the Safety and Tolerability of Pirfenidone (Esbriet®) in Combination With Nintedanib (Ofev®) in Patients With Idiopathic Pulmonary Fibrosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02598193
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 89 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 13, 2016
- Primary completion
- May 15, 2017
- Completion
- May 15, 2017
- Last update posted
- Jun 12, 2018
2016 – 2017
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| David Geffen School of Medicine at UCLA;Division of Pulmonary & Critical Care/ Department of Medic | Los Angeles | California | 90095-1690 | — |
| Stanford University School of Medicine ; Pulmonary/Critical Care Medicine | Stanford | California | 94305 | — |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109-0666 | — |
| Cardio-Pulmonary Associates of St. Luke's Hospital | Chesterfield | Missouri | 63017 | — |
| Creighton University | Omaha | Nebraska | 68131 | — |
| Atlantic Respiratory Institute | Summit | New Jersey | 07901 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Pulmonix LLC | Greensboro | North Carolina | 27403 | — |
| UC Health Clinical Trials Office | Cincinnati | Ohio | 45267 | — |
| John A. Butler, M.D. - Oregon Pulmonary Associates | Portland | Oregon | 97225 | — |
| Medical University of South Carolina (MUSC); MUSC Pulmonary | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Inova Health Care Services; Advanced Lung Disease Transplant Program | Falls Church | Virginia | 22042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02598193, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 12, 2018 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02598193 live on ClinicalTrials.gov.