Quercetin for COPD

(polyphenols Trial)

Overseen By Umadevi Sajjan

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Temple University

Must not be taking: Warfarin, Cyclosporine

Disqualifiers: Asthma, Lung cancer, Inflammatory bowel, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study determines whether quercetin supplementation reduces the inflammation and oxidative stress markers in patients with chronic obstructive pulmonary disease. It is small study with 8 subjects receiving quercetin 1000 mg/day, 8 patients receiving 500 mg/day and 4 subjects receive placebo.

Will I have to stop taking my current medications?

If you are taking H2 antagonists (like cimetidine or ranitidine), loperamide (Imodium), or loratadine, you will need to stop these medications during the study.

Is quercetin safe for human use?

Quercetin is generally considered safe for human use, with mild adverse effects rarely reported in studies. However, high doses may interact with certain medications and could pose risks for people with kidney issues or estrogen-dependent cancers. ^{1 2 3 4 5}

How is the drug quercetin different from other treatments for COPD?

Quercetin is unique because it not only reduces respiratory symptoms but also targets the root cause of exacerbations in COPD by reducing oxidative stress, lung inflammation, and rhinovirus-induced progression of lung disease. Unlike standard treatments, quercetin has antioxidant, anti-inflammatory, and antiviral properties that may help prevent the worsening of lung disease. ^{3 6 7 8 9}

What evidence supports the effectiveness of the drug Quercetin for treating COPD?

Research shows that Quercetin, a natural compound with antioxidant and anti-inflammatory properties, can reduce lung inflammation and improve lung function in animal models of COPD. It has been found to prevent the progression of lung disease caused by rhinovirus and cigarette smoke in mice, suggesting potential benefits for COPD patients. ^{3 6 7 10 11}

Who Is on the Research Team?

Nathaniel Marchetti, D.O

Principal Investigator

Temple University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your lung function test shows a specific ratio and percentage within a certain range.

I am between 40 and 80 years old with COPD.

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

Exclusion Criteria

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

Child-bearing age, who are unwilling to use adequate contraception or abstain during the course of the study

You do not have certain signs of inflammation in your blood or breath.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive quercetin or placebo for six months to assess its effects on oxidative stress and inflammatory markers in COPD

6 months

Monthly visits (in-person) for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Quercetin

Trial Overview 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.

How Is the Trial Designed?

Group I: Quercetin 1000 mg/day Active Control 1 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/day Active Control 1 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: Placebo Placebo Group 1 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.

Quercetin is already approved in United States for the following indications:

Approved in United States as Quercetin for:

• Herbal Supplementation
• Nonbacterial Chronic Prostatitis
• Interstitial Cystitis

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Quercegen Pharmaceuticals

Industry Sponsor

Trials

9

Recruited

310+

Published Research Related to This Trial

Quercetin supplementation at doses up to 2000 mg/day was found to be safe for patients with chronic obstructive pulmonary disease (COPD), with no severe adverse events reported during a 1-week study involving COPD patients with varying severity of lung disease.

The study indicated that quercetin could potentially be a beneficial natural treatment for managing COPD, as it was well-tolerated and did not lead to significant negative effects on lung function or blood profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical trial to determine the safety of quercetin supplementation in patients with chronic obstructive pulmonary disease. Han, MK., Barreto, TA., Martinez, FJ., et al.[2021]

In a mouse model of chronic obstructive pulmonary disease (COPD), quercetin, an antioxidant and anti-inflammatory agent, significantly reduced lung inflammation and other harmful changes caused by rhinovirus infection.

Quercetin supplementation not only alleviated the acute effects of rhinovirus on lung function but also suggests potential for preventing the progression of lung disease in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quercetin prevents rhinovirus-induced progression of lung disease in mice with COPD phenotype. Farazuddin, M., Mishra, R., Jing, Y., et al.[2018]

Quercetin shows promising antihypertensive effects and improves endothelial function in humans, suggesting it could help prevent cardiovascular diseases.

It enhances physical power and has anti-inflammatory and immunomodulatory properties, making it a potential candidate for preventing obesity-related diseases, although more human trials are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quercetin: potentials in the prevention and therapy of disease. Bischoff, SC.[2022]

In a study involving mice with COPD-like symptoms induced by elastase and LPS, quercetin treatment improved lung function by enhancing elastic recoil and reducing lung inflammation and oxidative stress over a 10-day period.

Quercetin was found to decrease the activity and expression of harmful enzymes (MMP9 and MMP12) associated with lung damage, suggesting it may help prevent the progression of emphysema through its antioxidant and anti-inflammatory properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quercetin prevents progression of disease in elastase/LPS-exposed mice by negatively regulating MMP expression. Ganesan, S., Faris, AN., Comstock, AT., et al.[2022]

In a study with 35 mice exposed to cigarette smoke for 60 days, quercetin treatment (10 mg/kg/day) significantly reduced oxidative damage and inflammation in the lungs, suggesting its protective effects against COPD-related changes.

Mice treated with quercetin showed improved lung histology and reduced symptoms of pulmonary emphysema compared to those only exposed to cigarette smoke, indicating its potential as a therapeutic agent in preventing lung damage from smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quercetin Improves Pulmonary Function and Prevents Emphysema Caused by Exposure to Cigarette Smoke in Male Mice. Araújo, NPDS., de Matos, NA., Oliveira, M., et al.[2022]

Isolated quercetin, commonly taken as a dietary supplement in doses up to 1000 mg per day, has shown a good safety profile in human studies, with only mild adverse effects reported.

However, there is a lack of long-term safety data for high doses of quercetin (≥1000 mg) beyond 12 weeks, and animal studies suggest potential risks such as enhancing kidney toxicity and promoting tumor development in certain cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Aspects of the Use of Quercetin as a Dietary Supplement. Andres, S., Pevny, S., Ziegenhagen, R., et al.[2019]

A review of 25 websites selling high-dose quercetin supplements revealed that while most products contained quercetin levels within 10% of their labeled amounts, one product had nearly 30% more than stated, highlighting potential inconsistencies in supplement labeling.

Many quercetin products were marketed with misleading health claims, and their high recommended doses (sometimes over 1,000 mg) could lead to significant interactions with prescription medications, indicating a need for caution among healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary quercetin supplements: Assessment of online product informations and quantitation of quercetin in the products by high-performance liquid chromatography. Vida, RG., Fittler, A., Somogyi-Végh, A., et al.[2019]

Quercetin and rutin significantly reduced airway resistance in asthmatic guinea pigs during both the immediate-phase and late-phase responses to an allergen, indicating their potential efficacy in asthma treatment.

Both compounds inhibited the production of inflammatory mediators like histamine and reduced the recruitment of immune cells such as neutrophils and eosinophils, suggesting they may help manage asthma symptoms through anti-inflammatory mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-asthmatic action of quercetin and rutin in conscious guinea-pigs challenged with aerosolized ovalbumin. Jung, CH., Lee, JY., Cho, CH., et al.[2019]

Quercetin Phytosome® does not affect the bleeding time in patients taking common antiplatelet medications like acetylsalicylic acid, ticlopidine, or clopidogrel, indicating it is safe to use alongside these drugs.

The supplement also does not alter INR levels in patients on anticoagulants like warfarin or dabigatran, nor does it impact blood sugar control in diabetic patients on metformin, suggesting it has a low risk of interaction with these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction study between antiplatelet agents, anticoagulants, diabetic therapy and a novel delivery form of quercetin. Riva, A., Corti, A., Belcaro, G., et al.[2022]

Quercetin treatment significantly improved the regeneration of airway epithelium in COPD patients' basal cells, leading to more ciliated cells and reduced goblet cells and IL-8 levels, indicating a potential therapeutic effect on airway repair.

In COPD patients, quercetin increased the expression of key developmental genes (HOXB2 and ELF3) associated with epithelial development, suggesting that it may enhance the healing process in damaged airways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quercetin improves epithelial regeneration from airway basal cells of COPD patients. McCluskey, ES., Liu, N., Pandey, A., et al.[2023]

Quercetin, a natural antioxidant found in many plants, has shown promising therapeutic effects for various eye diseases, including keratoconus and glaucoma, due to its antioxidant, anti-inflammatory, and anti-fibrosis properties.

The review highlights the potential of quercetin in treating a range of ophthalmic conditions, suggesting it could be a valuable addition to current treatment options for diseases affecting the eyes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The therapeutic use of quercetin in ophthalmology: recent applications. Zhao, L., Wang, H., Du, X.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Randomised clinical trial to determine the safety of quercetin supplementation in patients with chronic obstructive pulmonary disease. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Quercetin prevents rhinovirus-induced progression of lung disease in mice with COPD phenotype. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Quercetin: potentials in the prevention and therapy of disease. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Quercetin prevents progression of disease in elastase/LPS-exposed mice by negatively regulating MMP expression. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Quercetin Improves Pulmonary Function and Prevents Emphysema Caused by Exposure to Cigarette Smoke in Male Mice. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Safety Aspects of the Use of Quercetin as a Dietary Supplement. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Dietary quercetin supplements: Assessment of online product informations and quantitation of quercetin in the products by high-performance liquid chromatography. [2019]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Anti-asthmatic action of quercetin and rutin in conscious guinea-pigs challenged with aerosolized ovalbumin. [2019]

9. Italy pubmed.ncbi.nlm.nih.gov

Interaction study between antiplatelet agents, anticoagulants, diabetic therapy and a novel delivery form of quercetin. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Quercetin improves epithelial regeneration from airway basal cells of COPD patients. [2023]

11. France pubmed.ncbi.nlm.nih.gov

The therapeutic use of quercetin in ophthalmology: recent applications. [2021]