Idiopathic Pulmonary Fibrosis (IPF)NCT06650774
Comparison of the Efficacy of Pirfenidone and Nintedanipine in Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis (IPF), run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- How many people
- 152 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
1. Karadeniz Technical University Faculty of Medicine, Department of Chest Diseases
Trabzon, 61100
About this study
Official title: Comparison of the Effects of Nintedanib and Pirfenidone on Pulmonary Function Test Parameters and Radiological Findingsin Patients With Pulmonary Fibrosis
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.
Read more
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.
Read the detailed description
The data of 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 were retrospectively analyzed. The included patients had not previously used steroids or similar drugs for lung disease. The study was initiated after approval of the local ethics committee.
File information, pulmonary function test parameters and radiologic data, gender, age and comorbidity information of all patients were obtained from the hospital database. Pulmonary function tests were performed using a COSMED Quark 2021 model device. Patients were divided into two groups as nintedanib and pirfenidone group and both groups were compared in terms of progression in pulmonary function tests and radiologic findings within 1 year of diagnosis. For this purpose, the difference of pulmonary function test parameters (FVC (mL-%), FEV1 (mL-%), FEV1/FVC, FEF25-75 (mL-%), and 6-minute walk test values at the 3rd, 6th, 9th and 12th months of all patients from the baseline values at the time of diagnosis were analyzed and these differences were compared between the two groups.Thorax CT findings were also compared between the two groups for the presence of progression. 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, and patients who were switched between the two drugs before 1 year had elapsed were excluded from the study.
Statistical analysis Kolmogorov-Smirnov test was used to test the normal distribution of the continuous variables. The data characterized by a normal distribution are expressed as mean±standard deviation. Student's t-tests was used for the comparison of the data which had a normal distribution. Mann-Whitney-U test was used for the comparison of the non-normally distributed data. The discrete variables were compared using Chi-squared test. P <0.05 was considered to be statistically significant. The data were analyzed using the SPSS statistical software (version 13.01, serial number 9069728, SPSS Inc., Chicago).
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- Pulmonay Fibrosis, Pirfenidone, Nintedanib
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Pirfenidone Group | |
| Group 2 | Nintedanibe Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January 1 2010 and December 31 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start15 Jun 2024
- Primary completion30 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olcay Ayçiçek, Karadeniz Technical University
- Investigators
- Olcay Aycicek, Asist Prof, Principal investigator, 1. Karadeniz Technical University Faculty of Medicine, Department of Chest Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650774
- Sponsor's protocol ID
- 2024/111
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I prefer to leave it until after the publication of the article
Publications
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.
PubMed 28664861
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Nintedanib and Pirfenidone on Pulmonary Function Test Parameters and Radiological Findingsin Patients With Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT06650774
- Acronym / sponsor ID
- 2024/111
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- Pulmonay Fibrosis, Pirfenidone, Nintedanib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The data of 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 were retrospectively analyzed. The included patients had not previously used steroids or similar drugs for lung disease. The study was initiated after approval of the local ethics committee.
File information, pulmonary function test parameters and radiologic data, gender, age and comorbidity information of all patients were obtained from the hospital database. Pulmonary function tests were performed using a COSMED Quark 2021 model device. Patients were divided into two groups as nintedanib and pirfenidone group and both groups were compared in terms of progression in pulmonary function tests and radiologic findings within 1 year of diagnosis. For this purpose, the difference of pulmonary function test parameters (FVC (mL-%), FEV1 (mL-%), FEV1/FVC, FEF25-75 (mL-%), and 6-minute walk test values at the 3rd, 6th, 9th and 12th months of all patients from the baseline values at the time of diagnosis were analyzed and these differences were compared between the two groups.Thorax CT findings were also compared between the two groups for the presence of progression. 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, and patients who were switched between the two drugs before 1 year had elapsed were excluded from the study.
Statistical analysis Kolmogorov-Smirnov test was used to test the normal distribution of the continuous variables. The data characterized by a normal distribution are expressed as mean±standard deviation. Student's t-tests was used for the comparison of the data which had a normal distribution. Mann-Whitney-U test was used for the comparison of the non-normally distributed data. The discrete variables were compared using Chi-squared test. P <0.05 was considered to be statistically significant. The data were analyzed using the SPSS statistical software (version 13.01, serial number 9069728, SPSS Inc., Chicago).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Pirfenidone Group |
| Group 2 | – | –Nintedanibe Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of pulmonary function test parameters of pirfenidone and nintedanip groups after 1-year follow-up
Time frame: January 1 2010 and December 31 2022
SFT values at 3, 6, 9 and 12 months were compared with baseline values and the difference between the two groups was analyzed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Background: PubMed 28664861Johannson 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.
- Individual participant dataSharing planned: Undecided. I prefer to leave it until after the publication of the article
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olcay Aycicek, Asist Prof principal investigator
1. Karadeniz Technical University Faculty of Medicine, Department of Chest Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis (IPF), run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pulmonary function test parameters of pirfenidone and nintedanip groups after 1-year follow-up (time frame: January 1 2010 and December 31 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06650774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.