Idiopathic Pulmonary Fibrosis With Acute ExacerbationNCT04996303
Efficacy of Steroid Pulse Therapy in Acute Exacerbation of Idiopathic Pulmonary Fibrosis (AE-IPF) Admitted in ER
A study testing Routine steroid administration group and Steroid pulse therapy group in people with Idiopathic Pulmonary Fibrosis With Acute Exacerbation, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis With Acute Exacerbation
- What is being tested?
- Routine steroid administration group and Steroid pulse therapy group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jul 2021to 18 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine
Seoul
About this study
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.
Read more
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
- Being tested
- Routine steroid administration group, Steroid pulse therapy group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine steroid administration groupDrug
Steroid administration with routine dose - Methylprednisolone 1 mg/kg 7 days → 0.5 mg/kg 7 days → 0.25 mg kg 7 days
Steroid pulse therapy groupDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Routine | Other | Routine steroid administration group Receives: Drug: Routine steroid administration group |
| Pulse | Other | Steroid pulse therapy group Receives: Device: Steroid pulse therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
mortality rate depending on the steroid dose will be evaluated.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start27 Jul 2021
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary Fibrosis With Acute ExacerbationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moo Suk Park, Principal investigator, Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996303
- Sponsor's protocol ID
- 4-2021-0746
- Status last verified
- Jul 2024
- First submitted
- 2 Aug 2021
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD could be shared with other researchers, including ILD specialists, especially laboratory data and underlying diseases.
Publications
Kim H, Jang HJ, Kim SY, La Woo A, Kim EY, Kwak SH, Lee EH, Choi JS, Byun MK, Kim CY, Yu I, Lee CY, Han CH, Park SC, Chung JH, Park JE, Park JW, Kim SH, Raghu G, Park MS; SAFER Trial Investigators. Pulse versus Nonpulse Corticosteroid Therapy in Acute Exacerbation of Idiopathic Pulmonary Fibrosis: A Multicenter, Randomized Clinical Trial (SAFER). Am J Respir Crit Care Med. 2026 Sep 30:aamag529. doi: 10.1093/ajrccm/aamag529. Online ahead of print.
PubMed 42813947
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Steroid Pulse Therapy in Acute Exacerbation of Idiopathic Pulmonary Fibrosis (AE-IPF) Admitted in ER
- ClinicalTrials.gov ID
- NCT04996303
- Acronym / sponsor ID
- 4-2021-0746
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine | Other | Drug: Routine steroid administration groupRoutine steroid administration group |
| Pulse | Other | Device: Steroid pulse therapy groupSteroid pulse therapy group |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine steroid administration groupSteroid administration with routine dose - Methylprednisolone 1 mg/kg 7 days → 0.5 mg/kg 7 days → 0.25 mg kg 7 days | Drug | Routine |
| Steroid pulse therapy groupSteroid 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 | Device | Pulse |
Primary outcome
mortality rate
Time frame: 3 months
mortality rate depending on the steroid dose will be evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Derived from this study: PubMed 42813947Kim H, Jang HJ, Kim SY, La Woo A, Kim EY, Kwak SH, Lee EH, Choi JS, Byun MK, Kim CY, Yu I, Lee CY, Han CH, Park SC, Chung JH, Park JE, Park JW, Kim SH, Raghu G, Park MS; SAFER Trial Investigators. Pulse versus Nonpulse Corticosteroid Therapy in Acute Exacerbation of Idiopathic Pulmonary Fibrosis: A Multicenter, Randomized Clinical Trial (SAFER). Am J Respir Crit Care Med. 2026 Sep 30:aamag529. doi: 10.1093/ajrccm/aamag529. Online ahead of print.
- Individual participant dataSharing planned: Undecided. The IPD could be shared with other researchers, including ILD specialists, especially laboratory data and underlying diseases.
Related trials for Idiopathic Pulmonary Fibrosis With Acute Exacerbation
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Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis
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Active, not recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moo Suk Park principal investigator
Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine steroid administration group and Steroid pulse therapy group in people with Idiopathic Pulmonary Fibrosis With Acute Exacerbation, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04996303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.