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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights
Study Summary
This trial will study if Fisetin can help people with CVID, a weak immune system disorder, compared to a placebo.
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.Check my eligibility
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.See study design
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 belowSelect...
My doctor thinks I might have lung disease due to common variable immune deficiency.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body Weight Changes
Secondary outcome measures
Adverse Events
Change in 6 minute walk test
Vital capacity
+4 moreSide effects data
From 2022 Phase 2 trial • 55 Patients • NCT047716117%
Rash
7%
hyperhidrosis
7%
Chest pain
7%
Diarrhea
7%
Sinusitis
7%
Infectious Rash
7%
Back Pain
7%
Headache
7%
Worsening Headache
7%
Dyspnea
7%
sore throat
3%
hypertension
3%
tachycardia
3%
amnesia
3%
asthma with exacerbation
3%
Anosmia
3%
migraine
3%
conjunctivitis
3%
rhinitis
3%
flu like symptoms
3%
Otitis media
3%
vertigo
3%
edema, hand, bilateral
3%
bacterial vaginosis
3%
ear pain, left
3%
cough
3%
Upper Respiratory Infection
3%
Epistaxis
3%
flatulence
3%
shortness of breath
3%
arthoplasty
3%
ageusia
3%
change in smell
3%
vomiting
3%
fatigue
3%
Colic Renal
3%
Nephrolithiasis Calcium Oxalate
3%
sneezing
3%
thrush
3%
right shoulder arthroscopy, rotator cuff, repair
3%
watering eyes (epiphora)
3%
Systolic murmur
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group
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
~170
Find a Location
Who is running the clinical trial?
Avni JoshiLead Sponsor
Avni Joshi, MD, MSPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People who are in prison, living in an institution, or who may have difficulty making their own decisions, such as those with dementia.IgA levels are abnormal.I am currently in the hospital or might need to be hospitalized soon.I am a woman who cannot become pregnant because I am postmenopausal or have been surgically sterilized.You currently smoke or use tobacco products.I was diagnosed with CVID at least 30 days ago according to international standards.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.You drink a lot of caffeine every day (400 mg or more).My doctor thinks I might have lung disease due to common variable immune deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: Fisetin Group
- Group 2: Placebo Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical experiment accepting volunteers currently?
"Data hosted on clinicaltrials.gov indicates that, as of October 21st 2021, this medical experiment is not currently enlisting participants. Nevertheless, there are 369 other trials actively recruiting patients at present time."
Answered by AI
To what degree is Fisetin Group a safe remedial option for patients?
"There is limited clinical data indicating the safety of Fisetin Group, thus it was assigned a score of 2 on our metric. As this trial is in Phase 2, there are no existing studies demonstrating its efficacy."
Answered by AI
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