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Biological Effects of Quercetin in COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Quercetin

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Inflammation, Oxidative stress, Plant polyphenol, Flavonols

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
Subjects with no detectable levels of inflammatory CRP or SP-D in blood and/or IL-
1β or 8-isoprostane in the exhaled breath condensate
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

Sites / Locations

Nathaniel MarchettiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Quercetin

Placebo

Arm Description

Quercetin 2000 mg/day Quercetin is provided as orange flavored soft chews and each chew will have 250 mg of quercetin Quercetin will be administered orally twice daily, one half dose (4 chews) in the morning after breakfast and one half dose (4 chews) in the evening after dinner for six months.

Placebo is also provided as soft chews 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 (4 chews) in the morning after breakfast and one half dose (4 chews) in the evening after dinner for six months.

Outcomes

Primary Outcome Measures

Oxidative stress markers

8-isoprostane

Inflammatory markers

Interleukin (IL)-1beta, IL-8, in bronchoalveolar lavage and C-reactive protein (CRP) and surfactant protein (SP)-D in serum

Secondary Outcome Measures

Quercetin

Levels of quercetin in blood and lung

Full Information

NCT ID

NCT03989271

First Posted

June 14, 2019

Last Updated

August 15, 2023

Sponsor

Temple University

Collaborators

National Institutes of Health (NIH), Quercegen Pharmaceuticals, National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT03989271

Brief Title

Biological Effects of Quercetin in COPD

Official Title

Impact of Quercetin on Inflammatory and Oxidative Stress Markers in COPD

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

May 30, 2024 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Temple University

Collaborators

National Institutes of Health (NIH), Quercegen Pharmaceuticals, National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 receive quercetin 2000 mg/day and 4 subjects receive placebo.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

Inflammation, Oxidative stress, Plant polyphenol, Flavonols

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Double blinded placebo controlled study

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Randomization codes will be generated by a study statistician at the begnining 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.

Allocation

Randomized

Enrollment

29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Quercetin

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Quercetin

Other Intervention Name(s)

placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Oxidative stress markers

Description

8-isoprostane

Time Frame

six months

Title

Inflammatory markers

Description

Interleukin (IL)-1beta, IL-8, in bronchoalveolar lavage and C-reactive protein (CRP) and surfactant protein (SP)-D in serum

Time Frame

six months

Secondary Outcome Measure Information:

Title

Quercetin

Description

Levels of quercetin in blood and lung

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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 Subjects with no detectable levels of inflammatory CRP or SP-D in blood and/or IL- 1β or 8-isoprostane in the exhaled breath condensate 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Umadevi Sajjan, Ph.D

Phone

2157077139

Uma.Sajjan@temple.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nathaniel Marchetti, D.O.

Organizational Affiliation

Temple University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nathaniel Marchetti

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NATHANIEL MARCHETTI, D.O.

Phone

215-707-9929

nathaniel.marchetti@tuhs.temple.edu

First Name & Middle Initial & Last Name & Degree

Umadevi Sajjan, Ph.D

Phone

2157077139

uma.sajjan@temple.edu

First Name & Middle Initial & Last Name & Degree

Nathaniel Marchetti, D.O

First Name & Middle Initial & Last Name & Degree

Umadevi Sajjan, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20920189

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

Results Reference

result

PubMed Identifier

29975735

Citation

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.

Results Reference

result

PubMed Identifier

22465313

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.

Results Reference

result

Links:

URL

http://clinicaltrials.gov/ct2/show/NCT01708278

Description

Phase I clinical trials to determine the safety of quercetin supplementation in COPD

Learn more about this trial

Biological Effects of Quercetin in COPD

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