Study on Idiopathic Pulmonary Fibrosis: Evaluating Pirfenidone and Nintedanib for Patients with Progressive Disease

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What is this study about?

This clinical trial is focused on studying a lung disease called idiopathic pulmonary fibrosis (IPF). IPF is a condition where the lungs become scarred and breathing becomes difficult over time. The study will explore the effectiveness of two medications, pirfenidone and nintedanib, which are already used to treat IPF. Nintedanib is also known by its code name, BIBF 1120. The trial will compare different treatment approaches: using both medications together, switching from one to the other, or continuing with just one of them.

The purpose of the study is to evaluate how these treatments affect the decline in lung function over a period of 24 weeks. Participants will take the medications in the form of capsules or tablets, and their lung function will be measured at the start of the study and then again at weeks 4, 12, and 24. This will help determine how well the treatments are working in slowing down the progression of the disease.

Throughout the study, the tolerance of the medications will also be monitored, which means checking how well participants can handle the treatment without significant side effects. The study will also look at other factors, such as the time it takes for participants to stop the medication permanently, any hospitalizations related to lung issues, and overall survival without hospital admissions. The goal is to find the most effective way to manage IPF and improve the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of the treatment groups. This assignment determines the specific treatment plan to be followed during the trial.

2 baseline assessment

A baseline assessment will be conducted to measure the forced vital capacity (FVC) using hospital spirometry. This assessment provides a starting point for evaluating changes over the course of the study.

3 treatment administration

The patient will receive one of the following treatments: Ofev 150 mg soft capsules (nintedanib) or Esbriet 267 mg film-coated tablets (pirfenidone).

The medication will be taken orally, with the dosage and frequency determined by the assigned treatment group. The patient must adhere to the prescribed regimen for the duration of the study.

4 follow-up assessments

Follow-up assessments will occur at week 4, week 12, and week 24. These assessments will involve measuring the FVC to monitor changes in lung function.

The assessments will help evaluate the effectiveness of the treatment in managing the progression of idiopathic pulmonary fibrosis.

5 monitoring and reporting

Throughout the study, the patient will be monitored for any side effects or changes in health status. It is important to report any new symptoms or concerns to the study team promptly.

The patient will also be asked to complete questionnaires about symptoms and quality of life at various points during the study.

6 end of study

At the end of the 24-week study period, a final assessment will be conducted to evaluate the overall impact of the treatment on lung function and quality of life.

The results will contribute to understanding the effectiveness of the treatment strategies for idiopathic pulmonary fibrosis.

Who Can Join the Study?

Patient aged 50 years or older.
Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) according to specific medical guidelines. This involves using special imaging tests and tissue samples to confirm the condition.
Patient must show signs of IPF getting worse in the past 12 months, even with treatment. This can be shown by:
- A decrease in lung function by 10% or more.
- A decrease in lung function by 5% to less than 10% and worsening breathing symptoms.
- A decrease in lung function by 5% to less than 10% and more scarring seen on lung images.
- Worsening breathing symptoms and more scarring seen on lung images.
Patient must have been taking a stable dose of either pirfenidone or nintedanib for at least 6 months, with good tolerance. These are medications used to treat IPF.
Patient must have a Forced Vital Capacity (FVC) of 45% or more of what is predicted for their age and size. FVC is a measure of lung function.
Patient must have a Forced Expiratory Volume in 1 second (FEV1) to FVC ratio of 0.70 or more. This is another measure of lung function.
Patient must have a life expectancy of at least 9 months, as judged by the doctor.
Patient must have given written consent to participate in the study.
Patient must be part of a social insurance program.

Who Cannot Join the Study?

Patients who are not diagnosed with idiopathic pulmonary fibrosis cannot participate. This is a lung disease where the cause is unknown.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
Patients who are part of a vulnerable population cannot participate. This usually means groups that need special protection, like children or pregnant women.
Patients who are not able to perform the required lung function tests cannot participate. These tests measure how well the lungs are working.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hôpital Avicenne	Bobigny	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier De La Cote Basque	Bayonne	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopitaux Prives De Metz	Vantoux	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Bretagne Atlantique	Vannes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Cuozmt Halijninyet Ukoabdsffiuea Rnpnr	Reims	France
Cihapr Hrunuvncobl Eh Uiysqmhcwiunf Di Lpdhsfm	Limoges	France
Cjrijf Hrlbcscyplr Uirzuahzzthjw Dr Dutfi	Dijon	France
Abcgebgfly Pjcwfuvt Hrcgcyag Dn Mwvlkzonq	Marseille	France
Bnvsvqxz Ubdiuxqfmc Hxlfoave Cglmqr	Besançon	France
Cfpfzh Houbtjkghnk Ricvbagr Uanlxlrrsyffq Dt Trutr	Tours	France
Cxts Dc Nvazd	Vandoeuvre Les Nancy	France
Gnjqsn Hrvtykghdww Ugtjjcybaopqv Ptsgr Pxqsupyfapu Er Nxtraqkpcqxf	Paris	France
Cpwedq Hqmadfbgkmq Rbswmwyo Dpudbhkngnlfsy	Angers	France
Hpakomma Ubhnfsiligstnu Spcqpqxeyg &kpdwvp Hootrgt dk Hxhkyyjqewk	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.04.2024

Trial locations

Investigated drugs:

Pirfenidone is a medication used to treat idiopathic pulmonary fibrosis, a condition that causes scarring of the lungs. It helps slow down the progression of the disease by reducing lung inflammation and fibrosis, which can help improve breathing and lung function over time.

Nintedanib is another medication used for idiopathic pulmonary fibrosis. It works by inhibiting certain enzymes that contribute to the formation of scar tissue in the lungs. This helps to slow the decline in lung function and manage symptoms associated with the disease.

Investigated diseases:

Idiopathic pulmonary fibrosis

Idiopathic Pulmonary Fibrosis – Idiopathic pulmonary fibrosis is a chronic lung disease characterized by the progressive scarring of lung tissue. This scarring, or fibrosis, leads to a gradual decline in lung function, making it increasingly difficult for the lungs to supply oxygen to the bloodstream. The exact cause of the disease is unknown, which is why it is termed “idiopathic.” Over time, individuals with this condition may experience worsening shortness of breath and a persistent dry cough. The disease typically progresses over several years, with the rate of progression varying among individuals. As the fibrosis worsens, it can lead to significant respiratory impairment.

Trial ID:

2024-511427-34-00

Protocol code:

69HCL19_0029

NCT ID:

NCT03939520

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Idiopathic Pulmonary Fibrosis: Evaluating Pirfenidone and Nintedanib for Patients with Progressive Disease

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