Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is associated with a poor prognosis, with a 3-month mortality rate of over 50%. To date, no treatment has been proven to be effective in AI-FPI. The interest of glucocorticoids is controversial and needs to be confirmed. This confirmation is mandatory to validate the improvement of the prognosis of EA-IPF under this treatment but also to search for unsuspected deleterious effects as it has been shown with immunosuppressants in stable idiopathic pulmonary fibrosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Hospitalier Paris Saint Joseph
• Treatments: Prednisone

Criteria

Inclusion Criteria:

1. Patient is ≥ 18 years of age

2. IPF or IPF (likely) diagnosis defined on 2018 international recommendations

3. Definite or suspected Acute Exacerbation defined by the international working group criteria after exclusion of alternative diagnoses of acute worsening

4. For women of childbearing age: efficient contraception for the duration of the study*

*Effective contraception is defined as any contraceptive method that is used consistently and appropriately and has a low failure rate (i.e., less than 1% per year)

5. Affiliation to the social security

6. 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

Exclusion Criteria:

1. Identified etiology for acute worsening (i.e.: infectious disease)

2. Known hypersensitivity to glucocorticoids or to any component of the study treatment

3. Patient requiring mechanical ventilation or already on mechanical ventilation

4. 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.

5. Active cancer

6. Patient on a lung transplantation waiting list

7. Treatment with glucocorticoids > 1 mg/kg/d from more than 7 days in the last 15 days

8. Patient participating to another interventional clinical trial

9. Documented pregnancy or lactation

10. Patient under tutorship or curatorship

11. Patient deprived of liberty

12. Patient under court protection