Comparison of the Efficacy of Pirfenidone and Nintedanipine in Pulmonary Fibrosis

NCT06650774 | Completed

• 1 other identifier: 2024/111
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Keywords

Pulmonay Fibrosis; Pirfenidone; Nintedanib

Outcome Measures

Primary Outcomes (1)

• Comparison of pulmonary function test parameters of pirfenidone and nintedanip groups after 1-year follow-up

  SFT values at 3, 6, 9 and 12 months were compared with baseline values and the difference between the two groups was analyzed.

  January 1 2010 and December 31 2022

Study Arms (2)

Group 1

Pirfenidone Group

Group 2

Nintedanibe Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients who were switched between the two drugs before 1 year had elapsed

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

1. Karadeniz Technical University Faculty of Medicine, Department of Chest Diseases

Trabzon, 61100, Turkey (Türkiye)

Location

Related Publications (1)

• Johannson KA, Strambu I, Ravaglia C, Grutters JC, Valenzuela C, Mogulkoc N, Luppi F, Richeldi L, Wells AU, Vancheri C, Kreuter M; Erice ILD Working Group. Antacid therapy in idiopathic pulmonary fibrosis: more questions than answers? Lancet Respir Med. 2017 Jul;5(7):591-598. doi: 10.1016/S2213-2600(17)30219-9.

  PMID: 28664861 BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Olcay Aycicek, Asist Prof

  1. Karadeniz Technical University Faculty of Medicine, Department of Chest Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist Proof

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: June 15, 2024
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

TU (1)