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 trial examines whether quercetin, a natural supplement, can reduce inflammation and oxidative stress in people with chronic obstructive pulmonary disease (COPD). Researchers will divide participants into three groups: one taking 1000 mg of quercetin daily, another taking 500 mg, and a third group receiving a placebo. The study seeks individuals with COPD who have a history of smoking and are willing to pause specific medications during the trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early-stage findings.

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

Research has shown that quercetin is generally safe for use. One study found that participants tolerated quercetin well, even at high doses of 2000 mg per day. Researchers assessed lung function, conducted blood tests, and used questionnaires to identify any issues. These findings suggest that lower doses, like the 500 mg and 1000 mg used in the trial, are likely safe as well. Known for its antioxidant effects, quercetin might help reduce inflammation, making it a promising option for people with chronic obstructive pulmonary disease (COPD). Overall, quercetin appears well-tolerated, with no major safety concerns reported at similar doses. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about quercetin for COPD because, unlike typical treatments that often focus on bronchodilation or reducing inflammation with steroids, quercetin is a natural flavonoid with antioxidant and anti-inflammatory properties. This means it may help protect lung tissue from oxidative damage and reduce inflammation in a different way than current medications. Additionally, quercetin is derived from plants and is administered orally, which could offer a more natural and potentially less invasive option for managing COPD symptoms compared to inhalers and other pharmaceuticals.

What evidence suggests that this trial's treatments could be effective for COPD?

This trial will compare different dosages of quercetin and a placebo to evaluate its effects on COPD. Studies have shown that quercetin can help reduce inflammation and stress, major issues in chronic obstructive pulmonary disease (COPD). Research indicates that people taking quercetin have experienced better lung function. It may also protect the lungs from damage caused by cigarette smoke, a common problem in COPD. Previous studies suggest that quercetin can aid lung repair by promoting cell growth. Overall, early findings suggest quercetin could be a promising option for supporting lung health in 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 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 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 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]

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, 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]

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]

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]

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]

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 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]

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.

arabjchem.org

arabjchem.org/a-critical-review-on-quercetin-bioflavonoid-and-its-derivatives-scope-synthesis-and-biological-applications-with-future-prospects/

A critical review on quercetin bioflavonoid and its derivatives

Quercetin was treated with 4 equivalents of benzyl bromide and 4 equivalents of K2CO3 to give 3,3′,4′,7-tetra-O-benzylquercetin, further reacted with methyl ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10170608/

The therapeutic potential of quercetin for cigarette smoking ...

Many studies have shown that quercetin's antioxidant and anti-inflammatory properties have positive therapeutic potential for CS-COPD.