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Cyclophosphamide for Acute Exacerbation of Idiopathic Pulmonary Fibrosis (EXAFIP)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Cyclophosphamide
Placebo
Corticosteroid (prednisolone)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Tenon

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Corticosteroid with placebo

Corticosteroid associated with Cyclophosphamide

Arm Description

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.

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

Outcomes

Primary Outcome Measures

"Early" survival
All cause of mortality at 3 months

Secondary Outcome Measures

Overall Survival
Overall Survival at M6 and M12
Respiratory disease-specific mortality
Respiratory disease-specific mortality at M3 and M6
Respiratory Morbidity
\Worsening dyspnea (0-100-mm visual analogue (VAS) scale anchored with 0 ''no breathlessness'' and 10 or 100 ''worst imaginable breathlessness". Worsening is defined an absolute decrease of 10 mm) Or Increase need of supplemental oxygen of more than 3l/min to obtained a SaO2 > 90% or decrease of PaO2 of more than 10 mmHg with the same rate of flow supplemental oxygen Or Decrease FVC of more than 10% of predicted value Or Decrease diffuse capacity for carbon monoxide (DLCO) of more than 15% prednisolone
Chest HRCT features (HRCT images will be scored at 5 levels)
Chest HRCT features at M3 and M6 compared to inclusion
Prognosis factors of AE-IPF
PFTs results before AE-IPF
Time to visit after clinical worsening
Laboratory evaluation (LDH, CRP) at AE diagnosis (composite)
Prognosis factors of AE-IPF
PaO2 at AE diagnosis
Prognosis factors of AE-IPF
Chest HRCT features at AE diagnosis compared to HRCT before AE-IPF (if available)
Prognosis factors of AE-IPF
Chest HRCT classification before AE-IPF (definite UIP, probable UIP, indeterminate), if available
Time to dispense treatment of AE-IPF
Hemorrhagic cystitis (occurence of hematuria on urine dipstick and pelvic pain and/or dysuria should lead to cystoscopy)
Number of Infectious disease
Diabetes mellitus (capillary blood glucose monitoring and fasting plasma glucose > 1.26 g/l)
Hypertension (Blood pressure > 160/100 mmHg)
Clinical laboratory evaluation (blood count, serum creatinin measurement composite) according to Common Terminology Criteria for Adverse Event (CTCAE).

Full Information

First Posted
March 16, 2015
Last Updated
June 27, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02460588
Brief Title
Cyclophosphamide for Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Acronym
EXAFIP
Official Title
Cyclophosphamide Added to Corticosteroid in the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Placebo-controlled Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid with placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Corticosteroid associated with Cyclophosphamide
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control group
Intervention Description
Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid (prednisolone)
Other Intervention Name(s)
Both groups
Intervention Description
All patients will receive non experimental medication with high dose of corticosteroid.
Primary Outcome Measure Information:
Title
"Early" survival
Description
All cause of mortality at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival at M6 and M12
Time Frame
6 months and 12 montns
Title
Respiratory disease-specific mortality
Description
Respiratory disease-specific mortality at M3 and M6
Time Frame
6 months
Title
Respiratory Morbidity
Description
\Worsening dyspnea (0-100-mm visual analogue (VAS) scale anchored with 0 ''no breathlessness'' and 10 or 100 ''worst imaginable breathlessness". Worsening is defined an absolute decrease of 10 mm) Or Increase need of supplemental oxygen of more than 3l/min to obtained a SaO2 > 90% or decrease of PaO2 of more than 10 mmHg with the same rate of flow supplemental oxygen Or Decrease FVC of more than 10% of predicted value Or Decrease diffuse capacity for carbon monoxide (DLCO) of more than 15% prednisolone
Time Frame
6 months
Title
Chest HRCT features (HRCT images will be scored at 5 levels)
Description
Chest HRCT features at M3 and M6 compared to inclusion
Time Frame
6 months
Title
Prognosis factors of AE-IPF
Description
PFTs results before AE-IPF
Time Frame
3 months
Title
Time to visit after clinical worsening
Time Frame
3 months
Title
Laboratory evaluation (LDH, CRP) at AE diagnosis (composite)
Time Frame
3 months
Title
Prognosis factors of AE-IPF
Description
PaO2 at AE diagnosis
Time Frame
3 months
Title
Prognosis factors of AE-IPF
Description
Chest HRCT features at AE diagnosis compared to HRCT before AE-IPF (if available)
Time Frame
3 months
Title
Prognosis factors of AE-IPF
Description
Chest HRCT classification before AE-IPF (definite UIP, probable UIP, indeterminate), if available
Time Frame
3 months
Title
Time to dispense treatment of AE-IPF
Time Frame
3 months
Title
Hemorrhagic cystitis (occurence of hematuria on urine dipstick and pelvic pain and/or dysuria should lead to cystoscopy)
Time Frame
6 months
Title
Number of Infectious disease
Time Frame
6 months
Title
Diabetes mellitus (capillary blood glucose monitoring and fasting plasma glucose > 1.26 g/l)
Time Frame
6 months
Title
Hypertension (Blood pressure > 160/100 mmHg)
Time Frame
6 months
Title
Clinical laboratory evaluation (blood count, serum creatinin measurement composite) according to Common Terminology Criteria for Adverse Event (CTCAE).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc NACCACHE, PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Tenon
City
Paris
Country
France

12. IPD Sharing Statement

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Cyclophosphamide for Acute Exacerbation of Idiopathic Pulmonary Fibrosis

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