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Biological Effects of Quercetin in COPD Phase II
NCT06003270 · Temple University
In plain English
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Official title
Effects of Quercetin on the Oxidative Stress and Inflammatory Markers in COPD Phase II
About this study
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.
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
* 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 design
Enrollment target: 30 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-11-01
Estimated completion: 2025-07-31
Last updated: 2024-04-08
Interventions
Drug: Quercetin 1000 mgDrug: Quercetin 500 MGDrug: Placebo
Primary outcomes
- • C-reactive protein (CRP), and surfactant protein (SP)-D in serum (six months)
- • Club cell protein 16 (CC16) pg/ml (six months)
Sponsor
Temple University · other
With: National Center for Complementary and Integrative Health (NCCIH), Quercegen Pharmaceuticals
Contacts & investigators
ContactUmadevi Sajjan · contact · uma.sajjan@temple.edu · 2157077139
InvestigatorNathaniel Marchetti · principal_investigator, Temple University
All locations (1)
Nathaniel MarchettiRecruiting
Philadelphia, Pennsylvania, United States