NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1061220085

Registered date:22/01/2023

Efficacy and safety of low dose-steroid treatment for acute exacerbation of idiopathic interstitial pneumonia

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAcute exacerbation of idiopathic interstitial pneumonia
Date of first enrollment24/08/2023
Target sample size10
Countries of recruitment
Study typeInterventional
Intervention(s)Day 1~ 3 Prednisolone 1.0mg/kg Day 4~ 10 Prednisolone 0.5mg/kg Day 11~ 17 Prednisolone 0.5mg/kg -5mg

Outcome(s)

Primary OutcomeTreatment success rate at day 18 from start of study treatment
Secondary Outcome1. Ratio of cases that meet the following conditions on day 18 of study treatment compared to the end date of steroid pulse therapy - Decrease in PaO2/FiO2 ratio due to interstitial pneumonia - Worsen of chest X-ray or CT findings due to interstitial pneumonia - Increase in the level of CRP - Increase in the level of KL-6 - Worsen of mMRC scale 2. Duration until discharge after start of study treatment 3. Cumulative recurrence rate of acute exacerbations at 60 days from the start of study treatment 4. Survival rate at 60 days from start of study treatment 5. Adverse events during the study treatment 6. Adverse events related to steroids at 60 days

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1. Over 18 years old 2. Witten informed consent 3. Patients with acute exacerbation of idiopathic interstitial pneumonia 4. Patients who do not require intubation or non- invasive ventilation 5. No progression of interstitial pneumonia on the 3rd day of steroid pulse therapy (methylprednisolone 1 g for 3 days)
Exclude criteria1. Patients receiving immunosuppressants 2. Patients with interstitial pneumonia other than idiopathic interstitial pneumonia (e.g. collagen vascular disease, pneumoconiosis, drug-induced pneumonia, radiation pneumonitis, sarcoidosis, hypersensitivity pneumonia) 3. Patients with serum creatinine over 1.5 times the upper limit of normal 4. Patients with serious complications 5. Patients who lack the ability to consent 6. Patients with hypersensitivity to prednisolone 7. Patients receiving desmopressin acetate hydrate 8. Pregnancy 9. Patients judged by the principal investigator or co-investigator to be inappropriate for this study

Related Information

Contact

Public contact
Name Masuda Takeshi
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, 734-8551, Japan Hiroshima Japan 734-8551
Telephone +81-822575196
E-mail ta-masuda@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital
Scientific contact
Name Masuda Takeshi
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, 734-8551, Japan Hiroshima Japan 734-8551
Telephone +81-822575196
E-mail ta-masuda@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital