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Flavonoid

Quercetin for COPD (polyphenols Trial)

Phase 2

Recruiting

Led By Nathaniel Marchetti

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

Must not have

Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) or loratadine and not willing to stop during study period

Women of child-bearing age and unwilling to take pregnancy test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months

Summary

This trial looks at how quercetin supplementation affects inflammation and oxidative stress in COPD patients. 8 took 1000mg, 8 500mg and 4 placebo.

Who is the study for?

This trial is for COPD patients aged 40-80 with a specific lung function profile, who have smoked at least the equivalent of 10 pack-years. Participants must not have certain infections or be on conflicting medications, and women of childbearing age must use contraception or abstain.

What is being tested?

The study tests if quercetin, a dietary supplement, can reduce inflammation and oxidative stress in COPD patients. It's a small-scale trial where participants are given either high-dose (1000 mg/day), low-dose (500 mg/day) quercetin, or placebo.

What are the potential side effects?

Quercetin may cause side effects such as headaches and tingling sensations. Since it's being tested for its anti-inflammatory properties, allergic reactions could occur in those sensitive to it.

Eligibility Criteria

Inclusion Criteria

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

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I have smoked at least 10 packs of cigarettes a year.

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I am willing to stop taking my COPD medications like H2 antagonists, loperamide, or loratadine during the study.

Exclusion Criteria

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

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I am not willing to stop taking my H2 antagonists, loperamide, or loratadine during the study.

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I am a woman of childbearing age and refuse to take a pregnancy test.

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I have not taken antibiotics for an infection in the last two weeks.

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My current primary diagnosis is asthma.

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I have not been hospitalized or needed emergency treatment in the last month.

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I take warfarin or cyclosporine daily.

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I have inflammatory bowel disease.

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I am not willing to stop taking flavonoid supplements.

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I have had an upper respiratory infection in the last two weeks.

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I have lung cancer or am currently receiving chemotherapy or radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and six 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

C-reactive protein (CRP), and surfactant protein (SP)-D in serum

Club cell protein 16 (CC16) pg/ml

Secondary study objectives

Quercetin

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Quercetin 1000 mg/dayActive Control1 Intervention

Quercetin 1000 mg/day Quercetin is provided as caplet and each caplet will have 500 mg of quercetin Quercetin will be administered orally twice daily, one half dose (1 caplet) in the morning after breakfast and one half dose (1 caplet) in the evening after dinner for six months.

Group II: Quercetin 500mg/dayActive Control1 Intervention

Quercetin 500 mg/day Quercetin is provided as caplet and each caplet will have 500 mg of quercetin Quercetin will be administered orally once daily, (1 caplet) in the morning after breakfast and matching placebo in the evening after dinner for six months. The placebo is added to match the number of caplets with 1000 mg/day arm

Group III: PlaceboPlacebo Group1 Intervention

Placebo is also provided as caplets 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 (1caplet) in the morning after breakfast and one half dose (1 caplet) in the evening after dinner for six months.

0 / 12Eligibility criteria met