Cyclophosphamide for Acute Exacerbation of Idiopathic Pulmonary Fibrosis

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a major event of IPF with an annual incidence between 5 and 10% and is responsible for the death of one third of IPF patients. When AE-IPF occurs, it is associated with poor survival with an overall mortality at 3 months upper of 50%. To date, no treatment has been proved to be effective in AE-IPF but the efficacy of cyclophosphamide (CYC) on survival has been suggested, mainly by retrospective series and needs to be confirmed. This confirmation is mandatory to improve prognosis of AE-IPF but also to avoid unsuspected deleterious effect as it as been shown with immunosuppressor in stable IPF.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Cyclophosphamide; Prednisolone

Criteria

Inclusion Criteria :

• ≥18 years of age

• Definite or probable IPF diagnosis defined on 2011 international recommendations

• Definite or suspicion of AE defined by IPFnet criteria after exclusion of alternative diagnosis of acute worsening.

• Efficient contraceptive method within 1 month for women and 3 months for men after the last dose of treatment

• Affiliation to the social security

• Able to understand and sign a written informed consent form

Exclusion Criteria:

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

• Known hypersensitivity or contra-indication to CYC or to any component of the study treatment

• Patient on mechanical ventilation

• Active bacterial, viral, fungal or parasitic infection

• Active cancer

• Patient on a lung transplantation waiting list

• Treatment with CYC in the last 12 months

• Patient participating to another clinical trial

• Pregnancy or lactation