What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include the antifibrotic agents nintedanib and pirfenidone. Nintedanib is associated with gastrointestinal side effects such as diarrhea, nausea, and vomiting, as well as liver enzyme elevations. Pirfenidone commonly causes gastrointestinal issues like nausea and dyspepsia, as well as skin-related side effects such as rash and photosensitivity. Both medications can lead to fatigue and weight loss. These treatments aim to slow disease progression and reduce acute exacerbations, similar to the potential effects of EGCG, which is being studied for its antioxidant and anti-inflammatory properties.

What prior FDA approvals exist?

The FDA has approved two primary antifibrotic medications for the treatment of Idiopathic Pulmonary Fibrosis (IPF): nintedanib and pirfenidone. Nintedanib is a tyrosine kinase inhibitor that targets multiple pathways involved in fibrosis, while pirfenidone has antifibrotic and anti-inflammatory properties. Both drugs have been shown to slow disease progression and reduce the frequency of acute exacerbations in IPF patients. The ongoing study of Epigallocatechin-3-gallate (EGCG), an antioxidant and anti-inflammatory agent derived from green tea, is exploring a novel treatment approach for pulmonary fibrosis, potentially complementing the mechanisms of the currently approved antifibrotic agents.

What other types of research exist?

Promising novel alternatives to EGCG for Idiopathic Pulmonary Fibrosis patients include nintedanib and pirfenidone. Both have shown efficacy in slowing disease progression and reducing acute exacerbations. Additionally, Ginkgo biloba extract EGb761 has demonstrated potential in attenuating pulmonary fibrosis by regulating macrophage balance and cellular apoptosis.

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Polyphenol

EGCG for Pulmonary Fibrosis

Phase 1

Recruiting

Led By Sydney Montesi

Research Sponsored by Hal Chapman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, aged 40-85 years old

Women of childbearing potential (WCBP) must have a negative serum pregnancy test within 1 week prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study

Must not have

Participant has baseline resting oxygen saturation of < 89% on room air or need for continuous oxygen use at baseline visit (Visit 2)

Any history of HCV or HBV infection, NASH/NAFLD, or cirrhosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 84

Summary

This trial is testing EGCG, a compound from green tea, in patients with idiopathic pulmonary fibrosis (IPF). The goal is to see if EGCG can safely reduce lung scarring. EGCG works by blocking harmful signals that cause lung tissue to harden. Epigallocatechin-3-gallate (EGCG) is a polyphenol and a major component of green tea, known for its potent antioxidant, anti-inflammatory, and anti-fibrotic properties.

Who is the study for?

This trial is for adults aged 40-85 with idiopathic pulmonary fibrosis (IPF) who meet specific lung function criteria and have been on a stable dose of nintedanib or pirfenidone. They must not drink more than a cup of green tea daily, agree to birth control if applicable, and expect to live at least 9 months. Exclusions include certain medication use, other serious health conditions, recent infections or investigational therapies.

What is being tested?

The study tests the safety of EGCG from green tea in different doses combined with standard IPF treatments (nintedanib or pirfenidone) compared to placebo. It's a multi-center, double-blind trial meaning neither participants nor researchers know who gets the real treatment versus placebo.

What are the potential side effects?

While side effects are being studied as part of this trial's purpose and aren't fully known yet, potential risks may include digestive issues due to oral intake of EGCG and typical side effects associated with nintedanib or pirfenidone like liver problems or photosensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 85 years old.

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I am a woman who can have children, tested negative for pregnancy, and will use birth control during the study.

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I can take pills and will follow the EGCG treatment plan.

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My lung function is at least half of what is expected for someone my age and size.

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I have been diagnosed with IPF according to the 2022 ATS criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need oxygen or my oxygen levels are below 89% without it.

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I have had hepatitis C or B, fatty liver disease, or cirrhosis.

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I am taking more than 10 mg/day of corticosteroids or its equivalent.

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I am currently taking digoxin and will continue to do so during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events (AE) by causality

Change in diffusing capacity for carbon monoxide (DLCO)

Change in forced vital capacity (FVC)

+21 more

Secondary study objectives

Change of serum biomarker COMP at day 14

Change of serum biomarker COMP at day 84

Change of serum biomarker Periostin at day 14

+3 more

Trial Design

6Treatment groups

Active Control

Placebo Group

Group I: EGCG 600 mg with NintedanibActive Control1 Intervention

Patients enrolled in this group will be given oral capsule EGCG 600 mg daily with doctor provided Nintedanib for 12 weeks.

Group II: EGCG 600 mg with PirfenidoneActive Control1 Intervention

Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.

Group III: EGCG 300 mg with PirfenidoneActive Control1 Intervention

Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Pirfenidone for 12 weeks.

Group IV: EGCG 300 mg with NintedanibActive Control1 Intervention

Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided Nintedanib for 12 weeks.

Group V: Placebo for EGCG 600 mgPlacebo Group1 Intervention

Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided Nintedanib or Pirfenidone. The number of placebo capsules will be equal to that of 600 mg EGCG.

Group VI: Placebo for EGCG 300 mgPlacebo Group1 Intervention

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include antifibrotic agents such as nintedanib and pirfenidone. Nintedanib works by inhibiting multiple tyrosine kinases involved in the pathways that lead to fibrosis, thereby slowing the progression of lung scarring. Pirfenidone exerts its effects by reducing fibroblast proliferation, collagen synthesis, and the production of pro-fibrotic cytokines. Both agents help to slow disease progression and reduce acute exacerbations, which is crucial for improving the quality of life and survival in IPF patients. Additionally, Epigallocatechin gallate (EGCG), an antioxidant and anti-inflammatory compound found in green tea, is being studied for its potential to reduce oxidative stress and inflammation, which are key contributors to the fibrotic process in IPF. These treatments are important as they target the underlying mechanisms of fibrosis and inflammation, offering hope for better disease management and outcomes for IPF patients.

Epigallocatechin-3-Gallate (EGCG), an Active Compound of Green Tea Attenuates Acute Lung Injury Regulating Macrophage Polarization and Krüpple-Like-Factor 4 (KLF4) Expression.(-)-Epigallocatechin-3-gallate Reduces Cigarette Smoke-Induced Airway Neutrophilic Inflammation and Mucin Hypersecretion in Rats.