Biological Effects of Quercetin in COPD Phase II

Chronic Obstructive Pulmonary Disease Clinical Trial

— polyphenols  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003270
• Other study ID #: 20190727
• Secondary ID: R33AT009991
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: Temple University
• Contact: Umadevi Sajjan
• Phone: 2157077139
• Email: uma.sajjan[@]temple.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Bronchitis
• Bronchitis, Chronic
• Chronic Obstructive Pulmonary Disease
• Emphysema
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Quercetin 1000 mg
Active comparator
• Quercetin 500 MG
Active comparator
• Placebo
Placebo comparator

Locations

Country	Name	City	State
United States	Nathaniel Marchetti	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Temple University	National Center for Complementary and Integrative Health (NCCIH), Quercegen Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (4)

Farazuddin M, Mishra R, Jing Y, Srivastava V, Comstock AT, Sajjan US. Quercetin prevents rhinovirus-induced progression of lung disease in mice with COPD phenotype. PLoS One. 2018 Jul 5;13(7):e0199612. doi: 10.1371/journal.pone.0199612. eCollection 2018. — View Citation

Ganesan S, Faris AN, Comstock AT, Chattoraj SS, Chattoraj A, Burgess JR, Curtis JL, Martinez FJ, Zick S, Hershenson MB, Sajjan US. Quercetin prevents progression of disease in elastase/LPS-exposed mice by negatively regulating MMP expression. Respir Res. — View Citation

Ganesan S, Faris AN, Comstock AT, Wang Q, Nanua S, Hershenson MB, Sajjan US. Quercetin inhibits rhinovirus replication in vitro and in vivo. Antiviral Res. 2012 Jun;94(3):258-71. doi: 10.1016/j.antiviral.2012.03.005. Epub 2012 Mar 23. — View Citation

Han MK, Barreto TA, Martinez FJ, Comstock AT, Sajjan US. Randomised clinical trial to determine the safety of quercetin supplementation in patients with chronic obstructive pulmonary disease. BMJ Open Respir Res. 2020 Feb;7(1):e000392. doi: 10.1136/bmjres — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-reactive protein (CRP), and surfactant protein (SP)-D in serum	The levels of these inflammatory markers will be measured at the time of recruitment (baseline) and after treatment with placebo or quercetin 500 g/day or 1000 mg/day in all the patients and	six months
Primary	Club cell protein 16 (CC16) pg/ml	The level of this anti-inflammatory marker in the serum will be measured at the time of recruitment (baseline) and after treatment with placebo, 500mg/day quercetin or 1000 mg/day quercetin	six months
Secondary	Quercetin	Concentration of quercetin in plasma will be determined at baseline and after treatment with study drugs	six months

External Links

•   Biological Effects of Quercetin in COPD
•   Phase I clinical trials to determine the safety of quercetin supplementation in COPD