Biological Effects of Quercetin in COPD

Sponsor

Temple University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03989271

Collaborator

National Institutes of Health (NIH) (NIH), Quercegen Pharmaceuticals (Industry), National Center for Complementary and Integrative Health (NCCIH) (NIH)

Enrollment

Location

Arms

31.9

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blinded placebo controlled studyDouble 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 :

Oct 1, 2019

Anticipated Primary Completion Date :

May 30, 2022

Anticipated Study Completion Date :

May 30, 2022

Arms and Interventions

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 Names: 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 Names: placebo

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 Names:

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 Names:

placebo

Outcome Measures

Primary Outcome Measures

Oxidative stress markers [six months]
8-isoprostane
Inflammatory markers [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

Quercetin [six months]
Levels of quercetin in blood and lung

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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