Efficacy of Steroid Pulse Therapy in Acute Exacerbation of Idiopathic Pulmonary Fibrosis (AE-IPF) Admitted in ER

NCT ID: NCT04996303

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-27
• Study Completion Date: 2024-07-18

Brief 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. 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.

1. 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

2. 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.)

3. 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

1. The level of inflammatory markers

2. Imaging improvement: chest x-ray or CT

3. Pulmonary function test: performed at the outpatient clinic before discharge or 12 weeks after the first visit for acute exacerbation

Conditions

Idiopathic Pulmonary Fibrosis With Acute Exacerbation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Routine

Routine steroid administration group

Group Type: OTHER

Routine steroid administration group

Intervention Type: DRUG

Steroid administration with routine dose - Methylprednisolone 1 mg/kg 7 days → 0.5 mg/kg 7 days → 0.25 mg kg 7 days

Pulse

Steroid pulse therapy group

Group Type: OTHER

Steroid pulse therapy group

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DEVICE

Eligibility Criteria

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.)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moo Suk Park

Role: PRINCIPAL_INVESTIGATOR

Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine

Locations

Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2021-0746

Identifier Type: -

Identifier Source: org_study_id