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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether quercetin, a natural compound in many fruits and vegetables, can reduce inflammation and stress markers in people with chronic obstructive pulmonary disease (COPD). Participants will receive either quercetin or a placebo (a look-alike chew with no active ingredients) to determine any noticeable differences. The trial seeks individuals with COPD who are smokers or ex-smokers and are currently taking certain medications but willing to pause them for the study. Participants must not have asthma, recent infections, or a history of lung cancer. As a Phase 1, Phase 2 trial, this study aims to understand how quercetin works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that quercetin is likely to be safe for humans?

Research has shown that quercetin is generally safe for people. One study found that taking up to 2000 mg of quercetin per day was well-tolerated, with no major issues. The study assessed lung function and blood tests, yielding positive results. Another review confirmed quercetin's safety, highlighting its benefits and good tolerance. These studies suggest that the treatment is well-tolerated and unlikely to cause major side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COPD?

Unlike standard treatments for COPD, which often include bronchodilators and corticosteroids, quercetin offers a novel approach. Quercetin is a natural antioxidant found in foods like apples and onions, and researchers are intrigued by its potential to reduce inflammation and oxidative stress in the lungs. This unique mechanism could complement or even enhance the effects of current medications, potentially offering relief with fewer side effects. Researchers are excited to see if quercetin can provide a more holistic and natural option for managing COPD symptoms.

What evidence suggests that quercetin might be an effective treatment for COPD?

Research has shown that quercetin might help reduce inflammation and stress from harmful molecules in people with chronic obstructive pulmonary disease (COPD). Early results suggest that quercetin can improve breathing and may protect the lungs from cigarette smoke damage. In this trial, some participants will receive quercetin, administered as orange-flavored soft chews, to evaluate its effects. Studies have found that taking up to 2000 mg of quercetin daily is safe and does not harm lung function or blood tests. Quercetin might also help repair lung tissues by supporting the growth of new cells. These early findings offer hope that quercetin could benefit people with COPD. ^{1 2 3 6 7}

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, 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 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 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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

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 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]

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, 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7047491/

Randomised clinical trial to determine the safety of ... Quercetin was safely tolerated up to 2000 mg/day as assessed by lung function, blood profile and COPD assessment test questionnaire.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06003270

Biological Effects of Quercetin in COPD Phase II This study determines whether quercetin supplementation reduces the inflammation and oxidative stress markers in patients with chronic obstructive pulmonary ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8868486/

Quercetin Improves Pulmonary Function and Prevents ... These results suggest that quercetin may be an agent in preventing pulmonary emphysema induced by cigarette smoke. Keywords: quercetin, cigarette smoke, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03989271?viewType=Table&id=NCT03989271&rank=1

Study Details | Biological Effects of Quercetin in COPD This study determines whether quercetin supplementation reduces the inflammation and oxidative stress markers in patients with chronic obstructive pulmonary ...

5. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-024-02742-0

Quercetin improves epithelial regeneration from airway basal ... These results indicate that quercetin may improve airway epithelial regeneration by increasing the expression of genes involved in epithelial development/ ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10674654/

Quercetin as a Therapeutic Product: Evaluation of Its ... Quercetin has antioxidant, anti-inflammatory, cardioprotective, antiviral, and antibacterial effects. It is found to be beneficial against cardiovascular ...

7. dovepress.com dovepress.com/quercetin-a-flavonoid-with-potential-for-treating-acute-lung-injury-peer-reviewed-fulltext-article-DDDT

Quercetin: a flavonoid with potential for treating acute lung ... A review by Ding et al thoroughly summarized the safety and reliability of Quercetin based on results from Phase I and Phase II clinical trials.