Chronic Obstructive Pulmonary Disease Clinical Trial
— QuercetinOfficial title:
Phase I/II Study to Determine the Safety and Efficacy of Quercetin in COPD Patients
Chronic obstructive pulmonary disease (COPD) is a progressive disorder of the lung parenchyma and airways, which is the third-leading cause of death in the USA. Current therapies for COPD are only partially effective and may also have side effects. Although increasing evidence indicates that quercetin supplementation may be beneficial in treating COPD, key methodological issues have not been resolved. The overall objective of this study is to determine the dosage of quercetin supplementation, bioavailability of quercetin, safety, dose-response relationship and appropriate biomarkers which reflect clinical outcomes in patients with COPD that is necessary for conducting large clinical trials in this patient population.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Subjects diagnosed with mild to moderate COPD (GOLD stage I, II and III)- - 10 pack-year smoking history or greater and ceased to smoke at least for 2 months prior to recruitment - Subjects taking H2 antagonists, Imodium or loratadine and willing to stop during the study period Exclusion criteria: - COPD subjects with >80% or <35% predicted - Current smokers - Known allergy/sensitivity to quercetin - Subjects with primary diagnosis of asthma - Upper respiratory tract infection within two weeks of the screening visit - Acute bacterial infection requiring antibiotics within two weeks of screening - Emergency treatment or hospitalization within one month of screening - Pregnant or lactating mothers - Women who don't consent to take pregnancy test - Unwillingness to stop flavonoid supplementation - Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by Bioflavonoid Food and Supplement Screener - Daily oral steroid treatment, warfarin, cyclosporine (neural, sandimmune), digoxin, fexofenadine, paclitaxel, diltiazem, saquinavir, selected chemotherapeutic agents (etoposide, vinblastine, vincristine, vindesine), antifungals (ketoconazole, itraconazole), protease inhibitors (amprenavir, indinavir, nelfinavir), verapamil, oral glucocorticoids, erythromycin, quinidine - Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) or loratadine and not willing to stop during study period - Lung cancer history or undergoing chemo- or radiation therapy - Inflammatory bowel disease - Child bearing age, who are unwilling to use adequate contraception or abstain during the course of the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institutes of Health (NIH), Quercegen Pharmaceuticals |
United States,
Bischoff SC. Quercetin: potentials in the prevention and therapy of disease. Curr Opin Clin Nutr Metab Care. 2008 Nov;11(6):733-40. doi: 10.1097/MCO.0b013e32831394b8. Review. — View Citation
Boots AW, Drent M, de Boer VC, Bast A, Haenen GR. Quercetin reduces markers of oxidative stress and inflammation in sarcoidosis. Clin Nutr. 2011 Aug;30(4):506-12. doi: 10.1016/j.clnu.2011.01.010. Epub 2011 Feb 15. — View Citation
Boots AW, Wilms LC, Swennen EL, Kleinjans JC, Bast A, Haenen GR. In vitro and ex vivo anti-inflammatory activity of quercetin in healthy volunteers. Nutrition. 2008 Jul-Aug;24(7-8):703-10. doi: 10.1016/j.nut.2008.03.023. — View Citation
Comstock AT, Ganesan S, Chattoraj A, Faris AN, Margolis BL, Hershenson MB, Sajjan US. Rhinovirus-induced barrier dysfunction in polarized airway epithelial cells is mediated by NADPH oxidase 1. J Virol. 2011 Jul;85(13):6795-808. doi: 10.1128/JVI.02074-10. Epub 2011 Apr 20. — View Citation
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;11:131. doi: 10.1186/1465-9921-11-131. — View Citation
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. — View Citation
Harwood M, Danielewska-Nikiel B, Borzelleca JF, Flamm GW, Williams GM, Lines TC. A critical review of the data related to the safety of quercetin and lack of evidence of in vivo toxicity, including lack of genotoxic/carcinogenic properties. Food Chem Toxicol. 2007 Nov;45(11):2179-205. Epub 2007 Jun 7. Review. — View Citation
Jin F, Nieman DC, Shanely RA, Knab AM, Austin MD, Sha W. The variable plasma quercetin response to 12-week quercetin supplementation in humans. Eur J Clin Nutr. 2010 Jul;64(7):692-7. doi: 10.1038/ejcn.2010.91. Epub 2010 Jun 2. — View Citation
Okamoto T. Safety of quercetin for clinical application (Review). Int J Mol Med. 2005 Aug;16(2):275-8. Review. — View Citation
Terao J, Murota K, Kawai Y. Conjugated quercetin glucuronides as bioactive metabolites and precursors of aglycone in vivo. Food Funct. 2011 Jan;2(1):11-7. doi: 10.1039/c0fo00106f. Epub 2010 Nov 17. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the plasma quercetin levels in COPD patients following supplementation with quercetin | Eligible COPD subjects will be supplemented with quercetin for one or four weeks and plasma quercetin levels will be measured prior to and after supplementation with quercetin or placebo. Safety of quercetin supplementation will also be determined based on blood and pulmonary function tests | One week in Phase I safety study and Four weeks in Phase II study | Yes |
Secondary | Determine the effects of quercetin supplementation on the markers of oxidative stress in COPD subjects | Oxidative stress markers will be measured prior to and after quercetin or placebo supplementation Protein carbonyls and nitrotyrosines reduced glutathione malondialdehyde. |
4 weeks supplementation | Yes |
Secondary | Determine the effects of quercetin supplementation on the markers of inflammation in COPD subjects | Sputum and blood levels of markers of inflammation will be measured prior to and after supplementation with placebo or quercetin IL-6 IL-8 sICAM-1 CD40L CC16 PARC/CCL18 surfactant D protein C-reactive protein in blood only |
4 Weeks supplementation | Yes |
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