Quercetin for COPD

Overseen By Umadevi Sajjan, Ph.D

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Temple University

Must not be taking: Warfarin, Cyclosporine

Disqualifiers: Asthma, Lung cancer, Inflammatory bowel, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

29 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are taking H2 antagonists, loperamide, or loratadine, you will need to stop these medications during the study. The protocol does not specify other medications, so it's best to discuss your specific situation with the study team.

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 mitigate the progression of lung disease caused by rhinovirus and cigarette smoke in mice, suggesting potential benefits for COPD patients. ^{1 2 3 4 5}

Is quercetin safe for human use?

Quercetin is generally considered safe for human use, with mild adverse effects rarely reported. However, high doses may interact with certain medications and could pose risks for people with kidney issues or estrogen-dependent cancer. ^{3 6 7 8 9}

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

Quercetin is unique because it is a natural antioxidant and anti-inflammatory compound that may help reduce lung inflammation and prevent the progression of lung disease caused by rhinovirus in COPD patients, unlike current treatments that mainly address symptoms. ^{1 2 3 10 11}

Research Team

Nathaniel Marchetti, D.O

Principal Investigator

Temple University

Eligibility Criteria

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.

Inclusion 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.

I am between 40 and 80 years old with COPD.

Exclusion Criteria

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

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

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

Timeline

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 impact on inflammatory and oxidative stress markers in COPD

6 months

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Quercetin

Trial Overview 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.

Participant Groups

Group I: Quercetin Active Control 1 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: Placebo Placebo Group 1 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.

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+

Quercegen Pharmaceuticals

Industry Sponsor

Trials

9

Recruited

310+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

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]

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]

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]

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]

Isoquercitrin, derived from rutin, has higher bioavailability than quercetin and exhibits protective effects against various health issues such as oxidative stress, cancer, and cardiovascular disorders, making it a promising candidate for food supplementation.

While isoquercitrin is generally safe at recommended doses (5.4 mg/kg/day), higher doses may lead to benign side effects and potential drug interactions, highlighting the importance of monitoring intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isoquercitrin: pharmacology, toxicology, and metabolism. Valentová, K., Vrba, J., Bancířová, M., 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]

References

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. 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]

7. Germany pubmed.ncbi.nlm.nih.gov

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

8. Italy pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Isoquercitrin: pharmacology, toxicology, and metabolism. [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]