Quercetin for COPD
(polyphenols Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Temple University
Must not be taking: Warfarin, Cyclosporine
Disqualifiers: Asthma, Lung cancer, Inflammatory bowel, others
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
36789How 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.
1231011Eligibility Criteria
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.
+1 more
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.
+12 more
Trial 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 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
Participant Groups
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.
3Treatment groups
Active Control
Placebo Group
Group I: Quercetin 1000 mg/dayActive Control1 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/dayActive Control1 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: PlaceboPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nathaniel MarchettiPhiladelphia, PA
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Who Is Running the Clinical Trial?
Temple UniversityLead Sponsor
National Institutes of Health (NIH)Collaborator
National Center for Complementary and Integrative Health (NCCIH)Collaborator
Quercegen PharmaceuticalsIndustry Sponsor
References
Randomised clinical trial to determine the safety of quercetin supplementation in patients with chronic obstructive pulmonary disease. [2021]Quercetin is a plant flavonoid and has potent antioxidant and anti-inflammatory properties. In a preclinical model of chronic obstructive pulmonary disease (COPD), quercetin reduced markers of both oxidative stress and lung inflammation and also reduced rhinovirus-induced progression of lung disease. Although quercetin appears to be an attractive natural alternative to manage COPD, the safety of quercetin supplementation in this population is unknown.
Quercetin prevents rhinovirus-induced progression of lung disease in mice with COPD phenotype. [2018]Acute exacerbations are the major cause of morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD). Rhinovirus, which causes acute exacerbations may also accelerate progression of lung disease in these patients. Current therapies reduces the respiratory symptoms and does not treat the root cause of exacerbations effectively. We hypothesized that quercetin, a potent antioxidant and anti-inflammatory agent with antiviral properties may be useful in treating rhinovirus-induced changes in COPD. Mice with COPD phenotype maintained on control or quercetin diet and normal mice were infected with sham or rhinovirus, and after 14 days mice were examined for changes in lung mechanics and lung inflammation. Rhinovirus-infected normal mice showed no changes in lung mechanics or histology. In contrast, rhinovirus-infected mice with COPD phenotype showed reduction in elastic recoiling and increase in lung inflammation, goblet cell metaplasia, and airways cholinergic responsiveness compared to sham-infected mice. Interestingly, rhinovirus-infected mice with COPD phenotype also showed accumulation of neutrophils, CD11b+/CD11c+ macrophages and CD8+ T cells in the lungs. Quercetin supplementation attenuated rhinovirus-induced all the pathologic changes in mice with COPD phenotype. Together these results indicate that quercetin effectively mitigates rhinovirus-induced progression of lung disease in a mouse model of COPD. Therefore, quercetin may be beneficial in the treatment of rhinovirus-associated exacerbations and preventing progression of lung disease in COPD.
Quercetin: potentials in the prevention and therapy of disease. [2022]Quercetin is discussed since several decades as a multipotent bioflavonoid with great potential for the prevention and treatment of disease. In the current review, we present the most recent findings on quercetin with regard to the pharmacology, the in-vitro and in-vivo effects in different cell systems and animal models, and the clinical effects in humans.
Quercetin prevents progression of disease in elastase/LPS-exposed mice by negatively regulating MMP expression. [2022]Chronic obstructive pulmonary disease (COPD) is characterized by chronic bronchitis, emphysema and irreversible airflow limitation. These changes are thought to be due to oxidative stress and an imbalance of proteases and antiproteases. Quercetin, a plant flavonoid, is a potent antioxidant and anti-inflammatory agent. We hypothesized that quercetin reduces lung inflammation and improves lung function in elastase/lipopolysaccharide (LPS)-exposed mice which show typical features of COPD, including airways inflammation, goblet cell metaplasia, and emphysema.
Quercetin Improves Pulmonary Function and Prevents Emphysema Caused by Exposure to Cigarette Smoke in Male Mice. [2022]Chronic obstructive pulmonary disease (COPD) is the major cause of morbidity and mortality worldwide, and cigarette smoke is a key factor in the development of COPD. Thus, the development of effective therapies to prevent the advancement of COPD has become increasingly essential. We hypothesized that quercetin protects lungs in mice exposed to long-term cigarette smoke. Thirty-five C57BL/6 mice were exposed to cigarette smoke (12 cigarettes per day) for 60 days and pretreated with 10 mg/kg/day of quercetin via orogastric gavage. After the experimental protocol, the animals were euthanized and samples were collected for histopathological, antioxidant defense, oxidative stress and inflammatory analysis. The animals exposed to cigarette smoke showed an increase in respiratory rate and hematological parameters, cell influx into the airways, oxidative damage and inflammatory mediators, besides presenting with alterations in the pulmonary histoarchitecture. The animals receiving 10 mg/kg/day of quercetin that were exposed to cigarette smoke presented a reduction in cellular influx, less oxidative damage, reduction in cytokine levels, improvement in the histological pattern and improvement in pulmonary emphysema compared to the group that was only exposed to cigarette smoke. These results suggest that quercetin may be an agent in preventing pulmonary emphysema induced by cigarette smoke.
Safety Aspects of the Use of Quercetin as a Dietary Supplement. [2019]The flavonoid quercetin is frequently found in low amounts as a secondary plant metabolite in fruits and vegetables. Isolated quercetin is also marketed as a dietary supplement, mostly as the free quercetin aglycone, and frequently in daily doses of up to 1000 mg d-1 exceeding usual dietary intake levels. The present review is dedicated to safety aspects of isolated quercetin used as single compound in dietary supplements. Among the numerous published human intervention studies, adverse effects following supplemental quercetin intake have been rarely reported and any such effects were mild in nature. Published adequate scientific data for safety assessment in regard to the long-term use (>12 weeks) of high supplemental quercetin doses (≥1000 mg) are currently not available. Based on animal studies involving oral quercetin application some possible critical safety aspects could be identified such as the potential of quercetin to enhance nephrotoxic effects in the predamaged kidney or to promote tumor development especially in estrogen-dependent cancer. Furthermore, animal and human studies with single time or short-term supplemental quercetin application revealed interactions between quercetin and certain drugs leading to altered drug bioavailability. Based on these results, some potential risk groups are discussed in the present review.
Dietary quercetin supplements: Assessment of online product informations and quantitation of quercetin in the products by high-performance liquid chromatography. [2019]Administration of the increasingly popular dietary supplements containing quercetin may interfere with drug therapy. We intended to evaluate the online availability and quercetin content of the high-dose mono-component quercetin products and to review the potential use of quercetin products and their interactions with drugs. We monitored the online access to quercetin-containing dietary supplements, collected the relevant information from the websites, procured selected products from the vendors, and subjected them to substance analysis. The quercetin content was quantified by an HPLC-UV method. Twenty-five websites offered mono-component quercetin products, and nine products were procured. The quercetin content of eight products differed only ±10% from the nominal dose, whereas one product contained almost 30% more quercetin. Misleading indications such as antitumor and cardiovascular effects were often found on the sellers' websites. Quercetin-containing dietary supplements are available online with misleading indications. The recommended daily doses are often high (occasionally over 1,000 mg), which may induce clinically relevant interactions with medications. Because high-quercetin content of dietary supplements was confirmed, health care professionals should be aware of the unregulated internet market of dietary supplements and should consider the interactions of these substances with drugs.
Anti-asthmatic action of quercetin and rutin in conscious guinea-pigs challenged with aerosolized ovalbumin. [2019]The effects of quercetin and rutin on the asthmatic responses were studied in ovalbumin (OA)-sensitized conscious guinea pigs challenged with aerosolized-OA. We measured the specific airway resistance (sRaw) in the double-chambered plethysmograph during the immediate-phase response (IAR) and late-phase response (LAR) at 3 approximately 10 min and 24 hr after OA challenge, respectively. We counted leukocytes in bronchoalveolar lavage fluid (BALF) using Wright's stain, as well as in lung tissue fixed with 10% formalin and stained with H & E stain. Quercetin and rutin (7.5 mg/kg, p.o.) significantly and dose-dependently inhibited both sRaw on IAR (31.60 and 26.44%) and LAR (29.87 and 28.69%) but with less efficacy than dexamethasone (3 mg/kg) and salbutamol (0.3 mg/kg), which inhibited IAR by 36.71 and 69.45%, and LAR by 67.23 and 0%, respectively, Quercetin and rutin (15 mg/kg) also inhibited production of histamine, PLA2, and EPO, and recruitment of leukocytes, particularly neutrophils and eosinophils, during LAR. respectively. Dexamethasone (3 mg/kg) also significantly reduced the recruitment of neutrophils, eosinophils, and lymphocytes in BALF, and salbutamol (0.3 mg/kg) reduced neutrophils and eosinophils with lower activity than dexamethasone. These results indicate that quercetin and rutin may be useful in the treatment of IAR and LAR in asthma via inhibition of histamine release, PLA2, and EPO, and reduced recruitment of neutrophils and eosinophils into the lung.
Interaction study between antiplatelet agents, anticoagulants, diabetic therapy and a novel delivery form of quercetin. [2022]In this pilot non-interference clinical study we evaluated possible interactions between Quercetin Phytosome® (Quercefit™), an innovative delivery form of quercetin, and antiplatelet agents, anticoagulants, and anti-diabetic therapy in otherwise healthy subjects.
Quercetin improves epithelial regeneration from airway basal cells of COPD patients. [2023]Airway basal cells from patients with chronic obstructive pulmonary disease (COPD) regenerate abnormal airway epithelium and this was associated with reduced expression of several genes involved in epithelial repair. Quercetin reduces goblet cell metaplasia and the expression of pro-inflammatory cytokines in COPD models. This study assessed whether quercetin improves epithelial regeneration from COPD airway basal cells.
The therapeutic use of quercetin in ophthalmology: recent applications. [2021]Quercetin is a natural flavonol antioxidant found in various plant sources and food samples. It is well known for its notable curative effects on the treatment of ophthalmic diseases due to various biological activities, such as antioxidant, anti-inflammatory, and anti-fibrosis activities. This review will discuss the latest developments in therapeutic quercetin for the treatment of keratoconus, Graves' orbitopathy, ocular surface, cataracts, glaucoma, retinoblastoma, and other retinal diseases.