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NCT06003270 | RECRUITING | Chronic Obstructive Pulmonary Disease

Biological Effects of Quercetin in COPD Phase II
Sponsor:

Temple University

Information provided by (Responsible Party):

Umadevi Sajjan

Brief 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.

Condition or disease

Chronic Obstructive Pulmonary Disease

Emphysema

Chronic Bronchitis With Airway Obstruction

Intervention/treatment

Quercetin 1000 mg

Quercetin 500 MG

Placebo

Phase

PHASE2

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : QUADRUPLE
Masking Description : Randomization codes will be generated by a study statistician at the beginning of the study and is provided to research pharmacist who will be dispensing the study drugs. The study drug bottles will be numbered with no information about the study drug. The randomization codes will not be revealed until all the data is collected and analyzed. Both placebo and quercetin will be similarly packaged and will have similar color, taste and texture.
Primary Purpose : TREATMENT
Official Title : Effects of Quercetin on the Oxidative Stress and Inflammatory Markers in COPD Phase II
Actual Study Start Date : 2023-11-01
Estimated Primary Completion Date : 2025-02-15
Estimated Study Completion Date : 2025-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Biological Effects of Quercetin in COPD Phase II

Location Details

NCT06003270

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Locations

RECRUITING

United States, Pennsylvania

Nathaniel Marchetti

Philadelphia, Pennsylvania, United States, 19140