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Biological Effects of Quercetin in COPD

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ClinicalTrials.gov Identifier: NCT03989271
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Quercegen Pharmaceuticals
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Umadevi Sajjan, Temple University

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Quercetin Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded placebo controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Impact of Quercetin on Inflammatory and Oxidative Stress Markers in COPD
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Quercetin

Arm Intervention/treatment
Active Comparator: Quercetin
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.
Drug: Quercetin
Placebo
Other Name: placebo

Placebo Comparator: Placebo

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.

Drug: Quercetin
Placebo
Other Name: placebo




Primary Outcome Measures :
  1. Oxidative stress markers [ Time Frame: six months ]
    8-isoprostane

  2. Inflammatory markers [ Time Frame: six months ]
    Interleukin (IL)-1beta, IL-8, in bronchoalveolar lavage and C-reactive protein (CRP) and surfactant protein (SP)-D in serum


Secondary Outcome Measures :
  1. Quercetin [ Time Frame: six months ]
    Levels of quercetin in blood and lung



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989271


Contacts
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Contact: Umadevi Sajjan, Ph.D 2157077139 Uma.Sajjan@temple.edu

Locations
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United States, Pennsylvania
Nathaniel Marchetti Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: NATHANIEL MARCHETTI, D.O.    215-707-9929    nathaniel.marchetti@tuhs.temple.edu   
Contact: Umadevi Sajjan, Ph.D    2157077139    uma.sajjan@temple.edu   
Principal Investigator: Nathaniel Marchetti, D.O         
Sub-Investigator: Umadevi Sajjan, Ph.D.         
Sponsors and Collaborators
Temple University
National Institutes of Health (NIH)
Quercegen Pharmaceuticals
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Nathaniel Marchetti, D.O. Temple University

Additional Information:
Publications of Results:
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Responsible Party: Umadevi Sajjan, Associate Professor, Temple University
ClinicalTrials.gov Identifier: NCT03989271     History of Changes
Other Study ID Numbers: 25738
R61AT009991 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Umadevi Sajjan, Temple University:
Inflammation
Oxidative stress
Plant polyphenol
Flavonols
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs