RecruitingPhase 2NCT06003270

Biological Effects of Quercetin in COPD Phase II

Effects of Quercetin on the Oxidative Stress and Inflammatory Markers in COPD Phase II

Sponsor

Temple University

Enrollment

30 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Obstructive Pulmonary Disease Emphysema Chronic Bronchitis With Airway Obstruction

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 receiving quercetin 1000 mg/day, 8 patients receiving 500 mg/day and 4 subjects receive placebo.

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria14

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