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Flavonoid
Quercetin for COPD
Phase 1 & 2
Recruiting
Led By Nathaniel Marchetti, D.O.
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Both active and ex-smokers with at least 10 pack-years history of smoking
COPD patients taking H2 antagonists, loperamide or loratadine and willing to stop during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights
Study Summary
This trial tests if quercetin can reduce inflammation and oxidative stress in COPD patients. 8 take quercetin, 4 take placebo.
Who is the study for?
This trial is for COPD patients aged 40-80, who are current or former smokers with a significant smoking history. They must have specific lung function test results and be willing to stop certain medications during the study. It's not for those allergic to quercetin, with asthma, recent infections or hospitalizations, high dietary quercetin intake, on warfarin/cyclosporine, with lung cancer treatments or inflammatory bowel disease.Check my eligibility
What is being tested?
The trial tests if taking quercetin (2000 mg/day) can reduce inflammation and oxidative stress in COPD patients compared to a placebo group. The small study involves 8 subjects on quercetin and 4 on placebo to see the biological effects of this supplement.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of quercetin may include headaches, tingling sensations, and mild stomach discomfort. Since it's being tested for its anti-inflammatory properties in COPD patients here, monitoring will likely focus on any respiratory symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have smoked at least 10 packs of cigarettes a year.
Select...
I have COPD and am willing to stop taking H2 antagonists, loperamide, or loratadine for the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Inflammatory markers
Oxidative stress markers
Secondary outcome measures
Quercetin
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: QuercetinActive Control1 Intervention
Quercetin 2000 mg/day Quercetin is provided as orange flavored soft chews and each chew will have 250 mg of quercetin Quercetin will be administered orally twice daily, one half dose (4 chews) in the morning after breakfast and one half dose (4 chews) in the evening after dinner for six months.
Group II: PlaceboPlacebo Group1 Intervention
Placebo is also provided as soft chews that is similar to quercetin in color, taste and texture and will contain all the stabilizers and the inactive ingredients that is present in the quercetin chews.
Placebo will be administered orally twice daily, one half dose (4 chews) in the morning after breakfast and one half dose (4 chews) in the evening after dinner for six months.
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Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,821 Total Patients Enrolled
Quercegen PharmaceuticalsIndustry Sponsor
8 Previous Clinical Trials
276 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
833 Previous Clinical Trials
669,424 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lung function test shows a specific ratio and percentage within a certain range after using a bronchodilator.I have smoked at least 10 packs of cigarettes a year.You do not have signs of inflammation in your blood or breath.I am of childbearing age and refuse to take a pregnancy test.I am taking H2 antagonists, loperamide, or loratadine and cannot stop during the study.I have lung cancer or am currently receiving chemotherapy or radiation.I am not willing to stop taking flavonoid supplements.I take warfarin or cyclosporine daily.I have had an upper respiratory infection in the last two weeks.You are consuming more than 150 mg of quercetin daily as measured by a specific screening tool for food and supplements.I have inflammatory bowel disease.I am between 40 and 80 years old with COPD.I have not been hospitalized or needed emergency care in the last month.I have COPD and am willing to stop taking H2 antagonists, loperamide, or loratadine for the study.You are allergic to quercetin.My current primary diagnosis is asthma.I have not taken antibiotics for an infection in the last two weeks.
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.
Who else is applying?
What site did they apply to?
Nathaniel Marchetti
What portion of applicants met pre-screening criteria?
Met criteria
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