Ended Therapeutic confirmatory (Phase III) idiopathic pulmonary fibrosis

Pragmatic management of progressive disease in idiopathic pulmonary fibrosis

EU CTIS ID: 2024-511427-34-00

What this study is testing

To evaluate the efficacy of combination therapy of pirfenidone and nintedanib as compared to switch monotherapy (pirfenidone or nintedanib) and to no change monotherapy (pirfenidone or nintedanib) based on the slope of the decline in the forced vital capacity (FVC) measured during 24 weeks by hospital spirometry performed at baseline, week 4, week 12 and week 2

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

Patient aged ≥ 50 years
Diagnosis of Idiopathic Pulmonary Fibrosis according to ATS/ERS/JRS/ALAT criteria (Raghu G et al, AJRCCM 2018). High-resolution computed tomography (HRCT) and histopathology patters are classified according to the table in protocol
Patient who fulfill at least 1 of the 4 criteria for IPF progression in the 12 months (+/- six months) before screening, despite antifibrotic treatment in clinical practice (if yes check the option(s)). These criteria are: 0 Relative decline in FVC ≥10% predicted 0 Relative decline in FVC ≥5-<10% predicted and worsened respiratory symptoms 0 Relative decline in FVC ≥5-<10% predicted and increased extent of fibrotic changes on chest imaging 0 Worsened respiratory symptoms and increased extent of fibrotic changes on chest imaging
Patient must have been on a stable dose of pirfenidone or nintedanib prescribed as first-line therapy for at least 6 months, with good tolerance of 1602 to 2403 mg per day of pirfenidone or 200 to 300 mg per day of nintedanib
Patient who has a FVC ≥ 45% of predicted (according to the GLI standard).
Patient who has a forced expiratory volume in 1-second (FEV1)/FVC ratio ≥ 0.70.

You likely can't join if

Patients under judicial protection.
Patient who had acute exacerbation of idiopathic pulmonary fibrosis within the previous 3 months
Patient who has a history of cigarette smoking within the previous 3 months
Patient who has received experimental therapy for IPF within the previous 4 weeks
Patient who is receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within the previous 2 weeks
Patient who received Immuno-suppressants (e.g. methotrexate, azathioprine, cyclophosphamide, cyclosporine, sirolimus, everolimus or other immunosuppressants) within the previous 4 weeks.

See the full eligibility criteria

Who can join

Patient aged ≥ 50 years
Diagnosis of Idiopathic Pulmonary Fibrosis according to ATS/ERS/JRS/ALAT criteria (Raghu G et al, AJRCCM 2018). High-resolution computed tomography (HRCT) and histopathology patters are classified according to the table in protocol
Patient who fulfill at least 1 of the 4 criteria for IPF progression in the 12 months (+/- six months) before screening, despite antifibrotic treatment in clinical practice (if yes check the option(s)). These criteria are: 0 Relative decline in FVC ≥10% predicted 0 Relative decline in FVC ≥5-<10% predicted and worsened respiratory symptoms 0 Relative decline in FVC ≥5-<10% predicted and increased extent of fibrotic changes on chest imaging 0 Worsened respiratory symptoms and increased extent of fibrotic changes on chest imaging
Patient must have been on a stable dose of pirfenidone or nintedanib prescribed as first-line therapy for at least 6 months, with good tolerance of 1602 to 2403 mg per day of pirfenidone or 200 to 300 mg per day of nintedanib
Patient who has a FVC ≥ 45% of predicted (according to the GLI standard).
Patient who has a forced expiratory volume in 1-second (FEV1)/FVC ratio ≥ 0.70.
Patient who has a life expectancy of at least 9 months according to the investigator opinion.
Patient who has provided his written informed consent to participate in the study
Patient affiliated to a social insurance regimen

What rules you out

Patients under judicial protection.
Patient who had acute exacerbation of idiopathic pulmonary fibrosis within the previous 3 months
Patient who has a history of cigarette smoking within the previous 3 months
Patient who has received experimental therapy for IPF within the previous 4 weeks
Patient who is receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within the previous 2 weeks
Patient who received Immuno-suppressants (e.g. methotrexate, azathioprine, cyclophosphamide, cyclosporine, sirolimus, everolimus or other immunosuppressants) within the previous 4 weeks.
Patient who has a history of a malignancy within the previous 2 years, with the exception of basal cell skin neoplasms. In addition, a malignant diagnosis or condition first occurring prior to 2 years must be considered cured, inactive, and not under current treatment
Patient who has any concurrent condition other than IPF that, in the Investigator’s opinion, is unstable and/or would impact the likelihood of survival for the study duration or the subject’s ability to complete the study as designed, or may influence any of the safety or efficacy assessments included in the study
Patient who has baseline resting oxygen saturation of < 88% on room air or supplemental oxygen.
Female patient who is pregnant or lactating, or is of child bearing potential (defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if ≤ 55 years or 12 months if > 55 years) and who did not agree to use highly effective methods of birth control throughout the study.
Patient who is currently on both pirfenidone and nintedanib
Patient who has already received pirfenidone and nintedanib either concomitantly or successively.
Patient who has a contra-indication to pirfenidone or nintedanib
Patient who has a liver function with elevations in ALT and AST >3 × upper limit of normal (ULN)
Patient with moderate and severe hepatic impairment classified as Child Pugh B and C
Patient who has a severe renal impairment (Creatinine Clearance <30 ml/min) or end stage renal disease requiring dialysis
Patient who has emphysema > 15% on HRCT or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.