Biological Effects of Quercetin in COPD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03989271|
Recruitment Status : Not yet recruiting
First Posted : June 18, 2019
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: Quercetin||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|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.|
|Official Title:||Impact of Quercetin on Inflammatory and Oxidative Stress Markers in COPD|
|Estimated Study Start Date :||September 25, 2019|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||August 31, 2020|
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.
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.
Other Name: placebo
- Oxidative stress markers [ Time Frame: six months ]8-isoprostane
- 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
- Quercetin [ Time Frame: six months ]Levels of quercetin in blood and lung
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989271
|Contact: Umadevi Sajjan, Ph.D||2157077139||Uma.Sajjan@temple.edu|
|United States, Pennsylvania|
|Nathaniel Marchetti||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19140|
|Contact: NATHANIEL MARCHETTI, D.O. 215-707-9929 email@example.com|
|Contact: Umadevi Sajjan, Ph.D 2157077139 firstname.lastname@example.org|
|Principal Investigator: Nathaniel Marchetti, D.O|
|Sub-Investigator: Umadevi Sajjan, Ph.D.|
|Principal Investigator:||Nathaniel Marchetti, D.O.||Temple University|