Biological Effects of Quercetin in COPD Phase II

Last updated: April 5, 2024
Sponsor: Temple University
Overall Status: Active - Recruiting

Phase

2

Condition

Bronchitis

Emphysema

Bronchiectasis

Treatment

Quercetin 1000 mg

Quercetin

Quercetin 500 MG

Clinical Study ID

NCT06003270
20190727
R33AT009991
  • Ages 40-80
  • All Genders

Study 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 Criteria

Inclusion

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 stopduring the study period

Exclusion

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 byBioflavonoid Food and Supplement Screener
  • Daily warfarin or cyclosporine (Neoral, Sandimmune)
  • Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) orloratadine 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 duringthe course of the study.
  • Pregnant or lactating mothers

Study Design

Total Participants: 30
Treatment Group(s): 4
Primary Treatment: Quercetin 1000 mg
Phase: 2
Study Start date:
November 01, 2023
Estimated Completion Date:
July 31, 2025

Study Description

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.

Connect with a study center

  • Nathaniel Marchetti

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

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