NCT04996303

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

Completed NA Last updated 26 July 2024

What this trial tests

NA trial testing Routine steroid administration group in Idiopathic Pulmonary Fibrosis With Acute Exacerbation in 100 participants. Completed in 18 July 2024.

Timeline

27 July 2021

Primary endpoint
18 July 2024

18 July 2024

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	27 July 2021
Primary completion	18 July 2024
Estimated completion	18 July 2024
Sites	1 location across South Korea

Drugs / interventions tested

• Routine steroid administration group — full drug profile →
• Steroid pulse therapy group

Conditions studied

• Idiopathic Pulmonary Fibrosis With Acute Exacerbation — all drugs for Idiopathic Pulmonary Fibrosis With Acute Exacerbation →

Sponsor

Yonsei University

Who can join

Adults 20 to 85, any sex, with Idiopathic Pulmonary Fibrosis With Acute Exacerbation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment of acute exacerbations of interstitial lung diseases with corticosteroids: Evidence?
   Hung CF, Raghu G. · · 2024 · cited 4× · PMID 38961640 · DOI 10.1111/resp.14788
2. Radiation-triggered acute exacerbation of progressive fibrotic interstitial lung diseases: 'Are we advancing the frontier or crossing a dangerous line?'
   Dimeas IE, Miziou A, Mitchell PD, Daniil Z, et al · · 2026 · PMID 42087338 · DOI 10.1177/17534666261446877