Cyclophosphamide for Acute Exacerbation of Idiopathic Pulmonary Fibrosis

NCT ID: NCT02460588

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-07-31

Brief 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.

Detailed Description

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 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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Corticosteroid with placebo

Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.

All patients will receive non experimental medication with high dose of corticosteroid.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.

Corticosteroid (prednisolone)

Intervention Type: DRUG

All patients will receive non experimental medication with high dose of corticosteroid.

Corticosteroid associated with Cyclophosphamide

Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.

All patients will receive non experimental medication with high dose of corticosteroid.

Intravenous Cyclophosphamide (CYC), 600 mg/m² (adapted to age and renal function, maximal dose of 1.2 g) at Day 0, Day 15, M1, M2

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.

Intravenous Cyclophosphamide (CYC), 600 mg/m² (adapted to age and renal function, maximal dose of 1.2 g) at Day 0, Day 15, M1, M2

Corticosteroid (prednisolone)

Intervention Type: DRUG

All patients will receive non experimental medication with high dose of corticosteroid.

Interventions

Cyclophosphamide

Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.

Intravenous Cyclophosphamide (CYC), 600 mg/m² (adapted to age and renal function, maximal dose of 1.2 g) at Day 0, Day 15, M1, M2

Intervention Type: DRUG

Placebo

Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.

Intervention Type: DRUG

Corticosteroid (prednisolone)

All patients will receive non experimental medication with high dose of corticosteroid.

Intervention Type: DRUG

Other Intervention Names

Control group; Both groups

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Marc NACCACHE, PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Tenon

Paris, , France

Countries

France

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Other Identifiers

2015-000492-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P 140908

Identifier Type: -

Identifier Source: org_study_id