Stratification and standardization of corticosteroid treatment of acute exacerbations of interstitial pneumonia according to its severity.

JRCT ID: jRCT1031220450

Registered date:21/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute exacerbation of interstitial pneumonia
• Date of first enrollment: 21/11/2022
• Target sample size: 15
• Study type: Interventional

Intervention(s)

Patients will be classified into score 0, 1, 2, or 3 based on the total score using a previously published scoring system based on P/F ratio, CRP, and chest CT images at the onset of acute exacerbation (Sci Rep. 2022 Jan 21;12(1):1134).
Steroids will be administered according to the following schedule according to the total score, and the total steroid dosage at 3, 6, and 12 months will be compared with that in previous cases of acute exacerbations.
Steroid administration method will be as follows for each score according to the Guide for Diagnosis and Treatment of Idiopathic Interstitial Pneumonia 2022. The dose of steroids should be increased as soon as possible in case of worsening of the disease.
Score 0: Start with PSL 0.5 mg/day and decrease the dose by 5 mg every 2 weeks up to 10 mg. Thereafter, the dose is reduced by 2.5 mg every 4 weeks and discontinued.
Score 1: Steroid pulse therapy (methylprednisolone 1 g for 3 days) for 1 course only. Additional courses may be given if the disease worsens.
The maintenance dose is then started at PSL 0.5 mg/day and reduced by 5 mg every 2 weeks up to 10 mg.
The dose is then reduced by 2.5 mg every 4 weeks to 5 mg over 8 weeks. If possible, discontinue.
Score 2,3: Steroid pulse therapy (methylprednisolone 1 g for 3 days) 1 g for 3 days. At this point, consider immunosuppressive drugs (cyclosporine, tacrolimus, CellCept, etc.).
The maintenance dose of PSL is then started at 0.5 mg/day, and the dose is reduced by 5 mg every 2 weeks to 10 mg. If the dose cannot be reduced, the combination of immunosuppressive drugs should be considered. After that, the dosage is reduced by 2.5 mg every 4 weeks, and the maintenance dosage is reduced to 5 mg over 8 weeks.

Outcome(s)

• Primary Outcome: Cumulative steroid dose at 3, 6, and 12 months

Secondary Outcome

(1) Comparison of steroid complications at 3, 6, and 12 months with previous cases matched for age and severity of acute exacerbation.
(ii) Prognosis at 3, 6, and 12 months, compared with previous cases matched for age and severity of acute exacerbations, and validation of the scoring system.
(iii) Percentage of patients who required increased doses of steroids after treatment according to the protocol, compared to previous cases matched for age and severity of acute exacerbation.
(iv) Bone density within 1 year after the onset of acute exacerbation will be measured and compared with bone density in the stable period.
(v) Effectiveness and efficacy after steroid administration PaO2/FiO2 ratio and SpO2/FiO2 ratio at onset, and chest CT images at 1, 3, and 6 months after onset will be compared.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both
• Include criteria: Patients diagnosed with acute exacerbation of interstitial pneumonia

Exclude criteria

Patients who cannot obtain written informed consent.
Patients who cannot use corticosteroids.

Related Information

• Primary Sponsor: Sakamoto Susumu