Biological Effects of Quercetin in COPD

• Status: Recruiting
• Trial end date: 2022-05-30
• Target enrollment: 0
• Participant gender: All

Summary

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 receive quercetin 2000 mg/day and 4 subjects receive placebo.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); National Institutes of Health (NIH); Quercegen Pharmaceuticals
• Treatments: Quercetin

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

• Subjects with no detectable levels of inflammatory CRP or SP-D in blood and/or IL-

1β or 8-isoprostane in the exhaled breath condensate

• 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