What side effects are associated with this type of intervention?

Common treatments for COPD include inhaled bronchodilators (such as LABAs and LAMAs), inhaled corticosteroids, and phosphodiesterase-4 inhibitors like roflumilast. Inhaled bronchodilators can cause side effects such as dry mouth, tremors, and palpitations. Inhaled corticosteroids may lead to oral thrush, hoarseness, and an increased risk of pneumonia. Roflumilast, which has anti-inflammatory properties, can cause gastrointestinal issues like diarrhea and weight loss, as well as psychiatric symptoms such as anxiety and depression. Antioxidant treatments like N-acetylcysteine are generally well-tolerated but can cause nausea and gastrointestinal discomfort. Quercetin, being studied for its anti-inflammatory and antioxidant effects, may offer benefits with potentially fewer side effects, but more research is needed to confirm its safety and efficacy.

What prior FDA approvals exist?

The FDA has approved several treatments for COPD that focus on reducing inflammation and oxidative stress. Notably, N-acetylcysteine (NAC) has been studied for its mucolytic and antioxidant properties, showing potential in reducing exacerbations and improving lung function. Additionally, phosphodiesterase-4 inhibitors like roflumilast have been approved for their anti-inflammatory effects, particularly in patients with severe COPD and chronic bronchitis. These treatments aim to manage symptoms and improve the quality of life for COPD patients, similar to the goals of quercetin supplementation being studied for its anti-inflammatory and antioxidant benefits.

What other types of research exist?

Promising alternatives to quercetin for COPD patients include N-acetylcysteine (NAC), which has shown efficacy in reducing exacerbations and improving mucus clearance, and resveratrol, which has demonstrated anti-inflammatory effects in experimental models. Additionally, glycopyrrolate, a long-acting muscarinic antagonist, has been effective in improving lung function and quality of life in COPD patients. These alternatives offer potential benefits in managing inflammation and oxidative stress in COPD.

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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

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months

Summary

This trial tests whether quercetin supplements can reduce inflammation and stress in COPD patients. Quercetin is a natural compound found in foods that may offer a safer alternative to current treatments by neutralizing harmful molecules and blocking inflammation. Quercetin is a plant flavonoid with potent antioxidant and anti-inflammatory properties, and it has shown promise in reducing oxidative stress and lung inflammation.

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.

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.

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 below

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

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I have COPD and am willing to stop taking H2 antagonists, loperamide, or loratadine for the study.

Exclusion Criteria

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

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

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I am taking H2 antagonists, loperamide, or loratadine and cannot stop during the study.

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

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I am not willing to stop taking flavonoid supplements.

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I take warfarin or cyclosporine daily.

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I have inflammatory bowel disease.

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

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My current primary diagnosis is asthma.

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

Inflammatory markers

Oxidative stress markers

Secondary study objectives

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.

0 / 10Eligibility 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 Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, corticosteroids, and antioxidants. Bronchodilators, such as beta agonists and muscarinic antagonists, work by relaxing the muscles around the airways, making it easier to breathe. Corticosteroids reduce inflammation in the airways, decreasing swelling and mucus production. Antioxidants like quercetin help to reduce oxidative stress and inflammation, which are key contributors to COPD progression. These treatments are crucial for managing symptoms, improving lung function, and reducing the frequency and severity of exacerbations in COPD patients.

Quercetin Improves Pulmonary Function and Prevents Emphysema Caused by Exposure to Cigarette Smoke in Male Mice.