Biological Effects of Quercetin in COPD Phase II

Launched by TEMPLE UNIVERSITY · Aug 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called quercetin in people with Chronic Obstructive Pulmonary Disease (COPD), which includes conditions like emphysema and chronic bronchitis that make it hard to breathe. The researchers want to see if taking quercetin can reduce inflammation and oxidative stress in the lungs, which are common issues for COPD patients. In this small study, some participants will take a daily dose of 1000 mg of quercetin, others will take 500 mg, and a third group will receive a placebo (a non-active pill).

To be eligible for this trial, participants need to be between 40 and 80 years old and have a specific level of lung function. They should have a history of smoking and need to be willing to stop taking certain medications during the study. If someone has allergies to quercetin, asthma, or certain infections, or has had recent hospital treatment, they won't be able to participate. Those who join can expect to take the supplement for a period and have their lung health monitored, helping researchers understand if quercetin could be beneficial for COPD patients.

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Eligibility criteria

• Inclusion Criteria:
• • Subjects with COPD, 40 - 80 yrs of age
• • Post-bronchodilator forced expiratory volume (FEV)1/forced vital capacity (FVC) ratio 0.7, FEV1% predicted between 40 to 70
• • Both active and ex-smokers with at least 10 pack-years history of smoking
• • COPD patients taking H2 antagonists, loperamide or loratadine and willing to stop during the study period
• Exclusion Criteria:
• • Known allergy/sensitivity to quercetin
• • Subjects with primary current 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 for any reasons
• • Unwillingness to stop flavonoid supplementation
• • Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by Bioflavonoid Food and Supplement Screener
• • Daily warfarin or cyclosporine (Neoral, Sandimmune)
• • 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
• • Women of child-bearing age and unwilling to take pregnancy test
• • Child-bearing age, who are unwilling to use adequate contraception or abstain during the course of the study.
• • Pregnant or lactating mothers