What side effects are associated with this type of intervention?

Common treatments for Interstitial Lung Disease (ILD) with anti-inflammatory and antioxidant properties, such as N-acetylcysteine (NAC), have been associated with several side effects. NAC, while used for its antioxidative effects, has been shown to increase the rate of serious adverse cardiac events. Other broadly targeted immunosuppressants, like prednisone and azathioprine, have demonstrated harm in clinical trials, including increased risk of infections and other systemic side effects. Endothelin receptor antagonists, another class of drugs studied for ILD, have been found to be potentially harmful, worsening oxygenation and disease progression. Therefore, while these treatments may offer some benefits, they also carry significant risks that need to be carefully managed.

What prior FDA approvals exist?

FDA-approved treatments for Interstitial Lung Disease (ILD) with anti-inflammatory and antioxidant properties include pirfenidone and nintedanib. Pirfenidone has anti-fibrotic and anti-inflammatory effects, while nintedanib is a tyrosine kinase inhibitor that also exhibits anti-inflammatory properties. Additionally, N-acetylcysteine, an antioxidant, has been studied for its potential benefits in ILD, although its efficacy remains controversial. These treatments aim to slow the progression of the disease and manage symptoms.

What other types of research exist?

Promising novel alternatives to Fisetin for ILD patients include: 1) Pirfenidone, which has anti-inflammatory and antioxidant effects and has shown efficacy in reducing disease progression in IPF patients. 2) Nintedanib, another antifibrotic agent with anti-inflammatory properties, which has been effective in slowing lung function decline in various fibrosing ILDs. 3) BI 1015550, a PDE4B inhibitor, which is a clinical drug candidate for the oral treatment of IPF, showing potential in recent studies. 4) Recombinant human pentraxin-2 (rhPTX-2), which has demonstrated long-term safety and efficacy in IPF patients.

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Senolytic

Fisetin for Immune Deficiency-Related Lung Disease

Phase 2

Waitlist Available

Led By Avni Joshi, MD, MS

Research Sponsored by Avni Joshi

Eligibility Criteria Checklist

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

Must have

Physician diagnosis of possible GLILD associated with CVID

Be older than 18 years old

Must not have

Patient currently hospitalized or under immediate consideration for hospitalization

Men who are unwilling to abstain from sex with WCBP or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months

Summary

This trial is testing whether a natural supplement called Fisetin can help people with common variable immunodeficiency (CVID). CVID patients often struggle with infections due to a weak immune system. Fisetin might help by reducing inflammation and strengthening their immune response.

Who is the study for?

This trial is for adults with Common Variable Immunodeficiency (CVID) and associated lung disease, who have been diagnosed according to international standards. Participants must not be pregnant or at risk of pregnancy without contraception, should not use tobacco or consume excessive caffeine, and must be capable of following the study's procedures.

What is being tested?

The trial is testing Fisetin, a dietary supplement, against a placebo to see if it can treat interstitial lung disease in patients with CVID. The effectiveness of Fisetin will be compared to that of an inactive substance to determine its potential as a treatment option.

What are the potential side effects?

While specific side effects are not listed here, participants may experience reactions typical for dietary supplements which could include digestive discomfort, allergic reactions or other symptoms depending on individual tolerance.

Eligibility Criteria

Inclusion Criteria

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

Select...

My doctor thinks I might have lung disease due to common variable immune deficiency.

Exclusion Criteria

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

Select...

I am currently in the hospital or might need to be hospitalized soon.

Select...

I am a man who agrees to use contraception or abstain from sex with women who can become pregnant, from the start of the treatment until 48 hours after the last dose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Body Weight Changes

Secondary study objectives

Adverse Events

Change in 6 minute walk test

Vital capacity

+4 more

Side effects data

From 2023 Phase 1 & 2 trial • 75 Patients • NCT04210986

38%

Arthralgia

15%

Pain in Extremity

12%

Lab Findings

12%

Nausea

Fatigue

Back Pain

Headache

Muscle Cramp

Flatulence

Rash Maculo-Papular

Dry Mouth

Covid 19

Bladder Perforation

Neoplasms

Rotator Cuff Injury

100%

80%

60%

40%

20%

Study treatment Arm

Fisetin

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Fisetin GroupExperimental Treatment1 Intervention

Subjects will receive the supplement, Fisetin, for 2 cycles of 2 consecutive days (first on days 0 \& 1 and then repeated on days 28 \& 29)

Group II: Placebo GroupPlacebo Group1 Intervention

Subjects will receive placebo for 2 cycles of 2 consecutive days (first on days 0 \& 1 and then repeated on days 28 \& 29)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fisetin

2016

Completed Phase 2

~250

0 / 3Eligibility 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

Common treatments for Interstitial Lung Disease (ILD) often target inflammation and oxidative stress, which are critical in disease progression. Glucocorticoids, such as prednisone, reduce inflammation by suppressing the immune response. N-acetylcysteine (NAC) acts as an antioxidant, replenishing intracellular glutathione levels to combat oxidative damage in lung tissues. These mechanisms are crucial for ILD patients as they help to slow disease progression, improve lung function, and enhance quality of life. The anti-inflammatory and antioxidant properties of treatments like Fisetin are particularly promising as they address these fundamental pathological processes.