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Biological Effects of Quercetin in COPD Phase II (polyphenols)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Quercetin
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

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 Marchetti

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Quercetin 1000 mg/day

Quercetin 500mg/day

Placebo

Arm Description

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.

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 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.

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

First Posted
August 15, 2023
Last Updated
August 15, 2023
Sponsor
Temple University
Collaborators
National Institutes of Health (NIH), Quercegen Pharmaceuticals, National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT06003270
Brief Title
Biological Effects of Quercetin in COPD Phase II
Acronym
polyphenols
Official Title
Effects of Quercetin on the Oxidative Stress and Inflammatory Markers in COPD Phase II
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
February 15, 2025 (Anticipated)
Study Completion Date
July 31, 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
No
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 receiving quercetin 1000 mg/day, 8 patients receiving 500 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

7. Study Design

Primary Purpose
Treatment
Study Phase
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 begnnining 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
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quercetin 1000 mg/day
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Quercetin 500mg/day
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
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
No
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
Phone
2157077139
Email
uma.sajjan@temple.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel Marchetti
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
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NATHANIEL MARCHETTI, D.O.
Phone
215-707-9929
Email
nathaniel.marchetti@tuhs.temple.edu
First Name & Middle Initial & Last Name & Degree
Umadevi Sajjan, Ph.D
Phone
2157077139
Email
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
No
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
PubMed Identifier
32071149
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/bmjresp-2018-000392.
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
URL
http://clinicaltrials.gov/ct2/show/NCT03989271
Description
Biological Effects of Quercetin in COPD

Learn more about this trial

Biological Effects of Quercetin in COPD Phase II

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