- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04996303
Efficacy of Steroid Pulse Therapy in Acute Exacerbation of Idiopathic Pulmonary Fibrosis (AE-IPF) Admitted in ER
Idiopathic pulmonary fibrosis is the most severe form of interstitial lung disease. It is known that the prognosis is poor due to extensive inflammation and fibrosis of the lung parenchyma. In case of acute exacerbation, the prognosis becomes worse. In early studies, the 3-month mortality rate reached 50-80%, and in a recent study, the 1-month survival rate was 66%, and the 3-month survival rate was 41%.
It is known that 20% of patients with IPF will experience acute exacerbations in their lifetime. The most commonly used treatment for such acute exacerbations is antibiotics and high-dose steroids, or steroid pulse therapy. However, its effectiveness is unclear, and the survival rate is still low. However, as there is no evident therapeutic agent other than steroids, it is included in the treatment guidelines, so conservative treatment is administered while steroids are administered to patients with acute exacerbation of idiopathic pulmonary fibrosis in most upper institutions.
There is no precise treatment other than steroids for patients with idiopathic pulmonary fibrosis-acute exacerbation, but the side effects of steroid administration cannot be overlooked. Therefore, a study is needed to confirm whether steroid pulse therapy is necessary or not.
Inclusion criteria
- Among patients with clinically or histologically confirmed idiopathic pulmonary fibrosis, patients who visited the emergency room with dyspnea symptoms
- Patients within 1 month of exacerbation of respiratory symptoms
- Patients with increased GGO or worsening of IPF on chest CT within the last 2 weeks
- Patients who understand the purpose of the clinical study and voluntarily agree to participate in this clinical study
- When it is determined that steroid administration is necessary under the judgment of the medical staff during the treatment process
Exclusion criteria
- Patients who complain of dyspnea symptoms due to causes other than the respiratory system, such as fluid overload, congestive heart failure, pulmonary embolism, etc.
- Patients whose respiratory symptoms have worsened for more than 1 month
- Persons who cannot read consent forms (eg. illiterate, foreigners, etc.)
Study design Using an open-label RCT randomization method, the administration will be divided into Group 1 (high-dose followed by low-dose steroid administration) and Group 2 (high-dose/low-dose steroid administration after steroid pulse therapy).
- Test group: Group 1 (high dose followed by low dose steroid administration)
- Control group: Group 2 (high-dose/low-dose steroid administration after steroid pulse therapy) ▶ Steroid administration Protocol Group 1: Methylprednisolone 1 mg/kg 7 days → 0.5 mg/kg 7 days → 0.25 mg kg 7 days Group 2: Methylprednisolone 10 mg/Kg (500 mg ~ 1g) pulse 3 days -> Methylprednisolone 1 mg/kg 7 days → 0.5 mg/kg 7 days → 0.25 mg/kg 7 days
Response evaluation
- The level of inflammatory markers
- Imaging improvement: chest x-ray or CT
- Pulmonary function test: performed at the outpatient clinic before discharge or 12 weeks after the first visit for acute exacerbation
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Moo Suk Park
- Phone Number: 82-2-2228-1954
- Email: pms70@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine
-
Contact:
- Moo Suk Park
- Phone Number: +82-2-2228-1954
- Email: pms70@yuhs.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Among patients with clinically or histologically confirmed idiopathic pulmonary fibrosis, patients who visited the emergency room with dyspnea symptoms
- Patients within 1 month of exacerbation of respiratory symptoms
- Patients with increased GGO or worsening of IPF on chest CT within the last 2 weeks
- Patients who understand the purpose of the clinical study and voluntarily agree to participate in this clinical study
- When it is determined that steroid administration is necessary under the judgment of the medical staff during the treatment process
Exclusion Criteria:
- Patients who complain of dyspnea symptoms due to causes other than the respiratory system, such as fluid overload, congestive heart failure, pulmonary embolism, etc.
- Patients whose respiratory symptoms have worsened for more than 1 month
- Persons who cannot read consent forms (eg. illiterate, foreigners, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Routine
Routine steroid administration group
|
Steroid administration with routine dose - Methylprednisolone 1 mg/kg 7 days → 0.5 mg/kg 7 days → 0.25 mg kg 7 days
|
Other: Pulse
Steroid pulse therapy group
|
Steroid administration with pulse dose - Methylprednisolone 10 mg/Kg (500 mg ~ 1g) pulse 3 days -> Methylprednisolone 1 mg/kg 7 days → 0.5 mg/kg 7 days → 0.25 mg/kg 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality rate
Time Frame: 3 months
|
mortality rate depending on the steroid dose will be evaluated.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Moo Suk Park, Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2021-0746
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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