Acute exacerbation of idiopathic pulmonary fibrosis MedDRA version: 21.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: PREDNISONE
Product Name: PREDNISONE
Product Code: SUB10020MIG
Pharmaceutical Form: Oral solution in bottle
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Current Sponsor code: 2100370
Sponsors
Groupe Hospitalier Paris Saint-Joseph
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient is = 18 years of age 2) IPF or IPF (likely) diagnosis defined on 2018 international recommendations (See Appendix 1) (1) 3) Definite or suspected Acute Exacerbation defined by the international working group (2) criteria after exclusion of alternative diagnoses of acute worsening* (see below) 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) Birth control methods which may be considered as highly effective : • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal • progestogen-only hormonal contraception associated with inhibition of ovulation: o oral o injectable o implantable • intrauterine device (IUD) • intrauterine hormone-releasing system ( IUS) • bilateral tubal occlusion • vasectomised partner • sexual abstinence (highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments) Post-menopausal women : A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. 5) Affiliation to the social security 6) Patient able to understand and sign a written informed consent form *The criteria of IPF-AE are as follows: - Previous or concurrent diagnosis of IPF (a) - Acute worsening or development of dyspnea typically =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 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 or 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of glucocorticoids compared to placebo on mortality at Day 30 among patients with IPF-AE.;Secondary Objective: To evaluate among patients with IPF-AE the efficacy of glucocorticoids compared to placebo on: 1.Time to death 2.Overall mortality rate at Day 90 3.Death or transplantation at Day 90 4.Respiratory disease-specific mortality rate at Day 30 and 90 5.Time to worsening 6.Percentage of patients admitted to ICU 7.Percentage of patients requiring invasive ventilation 8.Length of hospital stay 9.Radiological evolution 10.Pulmonary function tests evolution Secondary Safety objectives To evaluate among patients with IPF-AE the safety of glucocorticoids compared to placebo in particular on the occurence of: 1.Infectious disease 2.Diabetes mellitus 3.Cardiovascular disorder 4.Neuropsychological disturbances 5.Clinical laboratory evaluation Other secondary objectives (exploratory) To compare both arms in terms of: 1.Dyspnea 2.Anxiety 3.Depression 4.Clinical status at day 15 as assessed on a 7-category ordinal scale;Primary end point(s): Parameter: all-cause mortality rate; Timetable: Day 30. The choice of all cause-mortality rate at Day 30 as the primary endpoint, has been driven by the results of our previous trial, EXAFIP. ;Timepoint(s) of evaluation of this end point: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy endpoints 1. Parameter: Time to death Methods: vital status assessment at Day 30 and Day 90 with time (in days) between randomization and death 2. Parameter: Overall mortality at Day 90 Methods: vital status assessment at Day 90 3. Parameter: Death or transplantation at Day 90 Methods: vital status and transplantation at Day 90 4. Parameter: Mortality linked to the respiratory disease at Day 30 and Day 90 Methods: cause of death assessment at Day 30 and Day 90 5. Parameter: Time to worsening Methods: Time (in days) from randomization to worsening* (see below) Timetable: From Day 4 to Day 30 (end of study treatment);Timepoint(s) of evaluation of this end point: 30 days or 90 days | — |
Countries
France
Contacts
Public ContactClinical Research Project Manager
Groupe Hospitalier Paris Saint-Joseph
Outcome results
None listed