Recruiting
Phase 2

Quercetin

Sponsor:

Temple University

Code:

NCT06003270

Conditions

Chronic Obstructive Pulmonary Disease

Emphysema

Chronic Bronchitis With Airway Obstruction

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Quercetin 1000 mg

Quercetin 500 MG

Placebo

Study Details

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.

Conditions

Chronic Obstructive Pulmonary Disease

Emphysema

Chronic Bronchitis With Airway Obstruction

Study ID

NCT06003270

Start date

Nov 1, 2023

Status verified date

Apr, 2024

Completion date

Jul 31, 2025

Anticipated

Primary completion date

Feb 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Quercetin 1000 mg/day

Quercetin 1000 mg/day Quercetin is provided as caplet and each caplet will have 500 mg of quercetin Quercetin will be administered orally twice daily, one half dose (1 caplet) in the morning after breakfast and one half dose (1 caplet) in the evening after dinner for six months.

active comparator: Quercetin 500mg/day

Quercetin 500 mg/day Quercetin is provided as caplet and each caplet will have 500 mg of quercetin Quercetin will be administered orally once daily, (1 caplet) in the morning after breakfast and matching placebo in the evening after dinner for six months.

The placebo is added to match the number of caplets with 1000 mg/day arm

placebo comparator: Placebo

Placebo is also provided as caplets that is similar to quercetin in color, taste and texture and will contain all the stabilizers and the inactive ingredients that is present in the quercetin chews.

Placebo will be administered orally twice daily, one half dose (1caplet) in the morning after breakfast and one half dose (1 caplet) in the evening after dinner for six months.

Interventions

Quercetin 1000 mg

Active comparator

Quercetin 500 MG

Active comparator

Placebo

Placebo comparator

Primary outcome measure

  • C-reactive protein (CRP), and surfactant protein (SP)-D in serum [ Time Frame: six months ]
  • Club cell protein 16 (CC16) pg/ml [ Time Frame: six months ]

Central Contacts and Locations

Central contacts

Umadevi Sajjan

2157077139uma.sajjan@temple.edu

Locations

Nathaniel Marchetti

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

NATHANIEL MARCHETTI, D.O.

215-707-9929nathaniel.marchetti@tuhs.temple.edu

Umadevi Sajjan, Ph.D

2157077139uma.sajjan@temple.edu

Principal Investigator:

Nathaniel Marchetti, D.O

More Information

Sponsor

Temple University

Last update posted

Apr 8, 2024

Last verified

Apr, 2024

Keywords

  • COPD, quercetin, polyphenol, mucus, airway obstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Temple University on 2024-04-08.