Acute exacebation of idiopathic pulmonary fibrosis IPF
Conditions
Interventions
Participants will be randomly assigned to two groups
a rapid tapering group and a standard tapering group, and will receive prednisolone treatment according to a prescribed dosage schedule.
Rapid tapering group
Days 1-4 (1-6): 1.0 mg/kg/day
Days 5-7 (3
Sponsors
Ichikado Kazuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients over 40 years of age 2) Patients who meet the diagnostic criteria for IPF or IPF Likely according to the American Thoracic Society/the European Respiratory Society/the Japanese Respiratory Society/the Latin American Thoracic Association 2022 international guidelines (Raghu G, et al. Am J Respir Crit Care Med 2018) 3) Patients who fulfill the diagnostic criteria for AE-IPF of the International Working Group in 2016 (Collard HR, et al. Am J Respir Crit Care Med 2016) 4) Patients who can obtain written consent from the patient or a surrogate 5) Patients whose steroid pulse therapy (mPSL > 500 mg) is initiated within 48 hours of admission and whose physician determines that subsequent steroid maintenance therapy is necessary
Exclusion criteria
Exclusion criteria: 1) Exacerbation due primarily to pulmonary infection, pneumothorax, pulmonary embolism, or left heart failure 2) Co-existing malignancy 3) Receiving mechanical ventilation by tracheal intubation 4) Pregnant, lactating, or possibly pregnant 5) Waiting for lung transplantation 6) Participating in another clinical trial (observational studies are acceptable) 7) Known hypersensitivity to any component of the study treatment 8) Positive for COVID-19, FluA, or FluB 9) Complications of fungal or acid-fast infection requiring treatment 10) Receiving steroid therapy with a PSL equivalent of 10 mg/day or more at the onset of acute exacerbation 11) Receiving immunosuppressive therapy at the onset of acute exacerbation 12) Patients whose respiratory status deteriorates during steroid pulse therapy 13) Patients deemed ineligible by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of untraceable Protocol compliance rate 28-day mortality Death from respiratory disease (up to 90 days) Time to respiratory deterioration (up to 90 days) 1-year mortality Hospitalization duration Dyspnea scales (mMRC, Modified Borg) ADL score (Barthel Index) Quality of life (EQ-5D) Clinical frailty scale Lung function tests (FVC, DLCO) Total steroid dose Delirium Serious adverse events Steroid-related adverse events | — |
Contacts
Public ContactKeisuke Anan
Saiseikai Kumamoto Hospital
Outcome results
None listed