Biological Effects of Quercetin in COPD Phase II

NCT06003270 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 20190727R33AT009991
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

COPD, quercetin, polyphenol, mucus, airway obstruction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Quercetin

  six months

Study Arms (3)

Quercetin 1000 mg/day

ACTIVE COMPARATOR

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.

Drug: Quercetin 1000 mg

Quercetin 500mg/day

ACTIVE COMPARATOR

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

Drug: Quercetin 500 MG

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Quercetin 1000 mg DRUG

Active comparator

Quercetin 1000 mg/day

Quercetin 500 MG DRUG

Active comparator

Quercetin 500mg/day

Placebo DRUG

Placebo comparator

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Quercegen Pharmaceuticals: collaborator

Study Sites (1)

Nathaniel Marchetti

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Related Publications (4)

• 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. 2010 Sep 28;11(1):131. doi: 10.1186/1465-9921-11-131.

  PMID: 20920189 RESULT

• 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.

  PMID: 29975735 RESULT

• 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.

  PMID: 22465313 RESULT

• 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/bmjresp-2018-000392.

  PMID: 32071149 RESULT

Related Links

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Airway Obstruction

Interventions

Quercetin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nathaniel Marchetti

  Temple University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Umadevi Sajjan

CONTACT

2157077139; uma.sajjan@temple.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double blinded placebo controlled study

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 21, 2023
• Study Start: November 1, 2023
• Primary Completion: February 15, 2025
• Study Completion: July 31, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)