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| ID | Type | Description | Link |
|---|---|---|---|
| R33AT009991 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Quercegen Pharmaceuticals | INDUSTRY |
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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.
Chronic obstructive pulmonary disease (COPD) is a progressive lung disorder and affects millions of people globally. Although the exact mechanisms of pathogenesis of this disease are not well-understood, the general consensus is that oxidative stress and inflammation induced by exposure to cigarette smoke or other environmental or occupational hazards are responsible for development of COPD. Therefore, therapies aimed at decreasing oxidative stress and inflammation constitutes an important component of treating COPD.
The current pharmacological therapies may provide temporary symptom relief, reduce acute exacerbations and hospitalizations, but are associated with side effects. Therefore complementary method of treatment with potentially fewer side effects and relatively well-tolerated provide promising alternative. One such compound is quercetin, which is plant polyphenol and is present in variety of foods that we consume. Quercetin has potent antioxidant and anti-inflammatory properties and reduces oxidative stress and inflammation in a preclinical model of COPD. Quercetin exerts it antioxidant properties not only by neutralizing free radical species, but also by enhancing the expression of antioxidant enzymes. Similarly, quercetin inhibits various protein and lipid kinases by competing for adenosine triphosphate (ATP) binding sites thus reducing the inflammatory pathways.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quercetin 1000 mg/day | Active Comparator | 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. |
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| Quercetin 500mg/day | Active Comparator | 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 |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quercetin 1000 mg | Drug | Active comparator |
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| Quercetin 500 MG |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein (CRP), and surfactant protein (SP)-D in serum | The levels of these inflammatory markers will be measured at the time of recruitment (baseline) and after treatment with placebo or quercetin 500 g/day or 1000 mg/day in all the patients and | six months |
| Club cell protein 16 (CC16) pg/ml | The level of this anti-inflammatory marker in the serum will be measured at the time of recruitment (baseline) and after treatment with placebo, 500mg/day quercetin or 1000 mg/day quercetin | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Quercetin | Concentration of quercetin in plasma will be determined at baseline and after treatment with study drugs | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Umadevi Sajjan | Contact | 2157077139 | uma.sajjan@temple.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Marchetti | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nathaniel Marchetti | Recruiting | Philadelphia | Pennsylvania | 19140 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20920189 | Result | Ganesan S, Faris AN, Comstock AT, Chattoraj SS, Chattoraj A, Burgess JR, Curtis JL, Martinez FJ, Zick S, Hershenson MB, Sajjan US. Quercetin prevents progression of disease in elastase/LPS-exposed mice by negatively regulating MMP expression. Respir Res. 2010 Sep 28;11(1):131. doi: 10.1186/1465-9921-11-131. | |
| 29975735 | Result | Farazuddin M, Mishra R, Jing Y, Srivastava V, Comstock AT, Sajjan US. Quercetin prevents rhinovirus-induced progression of lung disease in mice with COPD phenotype. PLoS One. 2018 Jul 5;13(7):e0199612. doi: 10.1371/journal.pone.0199612. eCollection 2018. |
| Label | URL |
|---|---|
| Phase I clinical trials to determine the safety of quercetin supplementation in COPD | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D011794 | Quercetin |
| ID | Term |
|---|---|
| D044948 | Flavonols |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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Double blinded placebo controlled study
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Randomization codes will be generated by a study statistician at the beginning of the study and is provided to research pharmacist who will be dispensing the study drugs. The study drug bottles will be numbered with no information about the study drug. The randomization codes will not be revealed until all the data is collected and analyzed. Both placebo and quercetin will be similarly packaged and will have similar color, taste and texture.
| Drug |
Active comparator |
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| Placebo | Drug | Placebo comparator |
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| 22465313 | Result | Ganesan S, Faris AN, Comstock AT, Wang Q, Nanua S, Hershenson MB, Sajjan US. Quercetin inhibits rhinovirus replication in vitro and in vivo. Antiviral Res. 2012 Jun;94(3):258-71. doi: 10.1016/j.antiviral.2012.03.005. Epub 2012 Mar 23. |
| 32071149 | Result | Han MK, Barreto TA, Martinez FJ, Comstock AT, Sajjan US. Randomised clinical trial to determine the safety of quercetin supplementation in patients with chronic obstructive pulmonary disease. BMJ Open Respir Res. 2020 Feb;7(1):e000392. doi: 10.1136/bmjresp-2018-000392. |
| Biological Effects of Quercetin in COPD | View source |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |