NCT06650774Completed
Comparison of the Efficacy of Pirfenidone and Nintedanipine in Pulmonary Fibrosis
Comparison of the Effects of Nintedanib and Pirfenidone on Pulmonary Function Test Parameters and Radiological Findingsin Patients With Pulmonary Fibrosis
Source: ClinicalTrials.gov · Last updated 21 Oct 2024
Brief summary (registry, in English)
The goal of this observational study is to compare the effects of pirfenidone and nintedanib on lung function and radiologic findings in fibrotic lung diseases. The main question it aims to answer is: • Do these two drugs have equivalent effects on progression in patients with pulmonary fibrosis? If there is a comparison group: The investigators will compare patients with pulmonary fibrosis receiving pirfenidone with patients with pulmonary fibrosis receiving nintedanip. The investigators will compare patients with pulmonary fibrosis receiving pirfenidone and patients with pulmonary fibrosis receiving nintedanip. Pulmonary function test parameters at 3rd, 6th, 9th and 12th months and differences of 6 MWT parameters compared to baseline will be compared between the two groups.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 152 (actual)
- First submitted
- 17 Oct 2024
- Start date
- 15 Jun 2024
- Primary completion date
- 30 Aug 2024
- Lead sponsor
- Karadeniz Technical University
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT06650774
What you commit to
- Study type: Observational
- Participants enrolled: 152
- From 15 Jun 2024 to the primary completion date, 30 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who were switched between the two drugs before 1 year had elapsed
Other
- Patients whose radiologic and PFT data at initial presentation were not available -Patients whose treatment was discontinued before 1 year due to side effects or unresponsiveness or death
Who the study is looking for
- The patients who were started Pirfenidone or Nintedanib treatment with the diagnosis of Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis according to An Official ATS/ERS/JRS/ALAT Clinical Practice guideline and treated for at least one year in our department between January 1 2010 and December 31 2022 The included patients had not previously used steroids or similar drugs for lung disease.
- Patients aged 18 years who have not used steroids or similar medication after diagnosis
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 1. Karadeniz Technical University Faculty of Medicine, Department of Chest Diseases Coordinator of this site? Confirm its status | Trabzon | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.