- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06003270
Biological Effects of Quercetin in COPD Phase II (polyphenols)
Effects of Quercetin on the Oxidative Stress and Inflammatory Markers in COPD Phase II
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Umadevi Sajjan
- Phone Number: 2157077139
- Email: uma.sajjan@temple.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19140
- Recruiting
- Nathaniel Marchetti
-
Contact:
- Umadevi Sajjan, Ph.D
- Phone Number: 2157077139
- Email: uma.sajjan@temple.edu
-
Contact:
- NATHANIEL MARCHETTI, D.O.
- Phone Number: 215-707-9929
- Email: nathaniel.marchetti@tuhs.temple.edu
-
Principal Investigator:
- Nathaniel Marchetti, D.O
-
Sub-Investigator:
- Umadevi Sajjan, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Quercetin 1000 mg/day
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.
|
Active comparator
|
Active Comparator: Quercetin 500mg/day
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 |
Active comparator
|
Placebo Comparator: Placebo
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. |
Placebo comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C-reactive protein (CRP), and surfactant protein (SP)-D in serum
Time Frame: six months
|
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
Time Frame: six months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quercetin
Time Frame: six months
|
Concentration of quercetin in plasma will be determined at baseline and after treatment with study drugs
|
six months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nathaniel Marchetti, Temple University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Disease Attributes
- Bronchial Diseases
- Respiratory Insufficiency
- Chronic Disease
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Emphysema
- Airway Obstruction
- Bronchitis
- Bronchitis, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Antioxidants
- Quercetin
Other Study ID Numbers
- 20190727
- R33AT009991 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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