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Glucocorticoids versus placebo for the treatment of acute exacerbation of idiopathic pulmonary fibrosis: a randomized controlled trial
EU CTIS ID: 2024-514799-42-00
What this study is testing
assess the efficacy of glucocorticoids compared to placebo on mortality at Day 30 among patients with IPF-AE
- Therapeutic exploratory (Phase II)
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 is ≥ 18 years of age
- IPF or IPF (likely) diagnosis defined on 2018 international recommendations
- Definite or suspected Acute Exacerbation defined by the international working group criteria after exclusion of alternative diagnoses of acute worsening
- For women of childbearing age: efficient contraception for the duration of the study
- Affiliation to the social security
- Patient able to understand and sign a written informed consent form or in case of incapacity of the patient to a relative whom understand and sign a written informed consent form
You likely can't join if
- Identified etiology for acute worsening (i.e.: infectious disease)
- Patient under tutorship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Known hypersensitivity to glucocorticoids or to any component of the study treatment
- Patient requiring mechanical ventilation or already on mechanical ventilation
See the full eligibility criteria
- Patient is ≥ 18 years of age
- IPF or IPF (likely) diagnosis defined on 2018 international recommendations
- Definite or suspected Acute Exacerbation defined by the international working group criteria after exclusion of alternative diagnoses of acute worsening
- For women of childbearing age: efficient contraception for the duration of the study
- Affiliation to the social security
- Patient able to understand and sign a written informed consent form or in case of incapacity of the patient to a relative whom understand and sign a written informed consent form
- Identified etiology for acute worsening (i.e.: infectious disease)
- Patient under tutorship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Known hypersensitivity to glucocorticoids or to any component of the study treatment
- Patient requiring mechanical ventilation or already on mechanical ventilation
- Active bacterial, viral, fungal or parasitic infection. On swab collected, only positive for SARS-CoV-2, Influenzae A, Influenzae B and Respiratory Syncytial Virus (RSV) result, are considered active viral infection. The others viruses (i.e. Rhinovirus, Adenovirus…) are not considered to be responsible of pneumonia.
- Active cancer
- Patient on a lung transplantation waiting list
- Treatment with glucocorticoids > 0.5 mg/kg/j for 3 consecutive days in the last 15 days OR treatment with glucocorticoids > 2 mg/kg/j for 3 consecutive days in the last 30 days Patient treated with long-term glucocorticoids ≤ 10mg/j for symptom management are eligible.
- Patient participating to another interventional clinical trial
- Documented pregnancy or lactation
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
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.