Beneficial Effects of Quercetin in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Quercetin; Placebo - sugar chew
Intervention description: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin; COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)
Intervention MeSH terms: Folic Acid; Quercetin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 9.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD; Emphysema; chronic bronchitis; Quercetin; flavonoids

Summary:

      Chronic obstructive pulmonary disease (COPD) is a progressive disorder of the lung parenchyma
      and airways, which is the third-leading cause of death in the USA. Current therapies for COPD
      are only partially effective and may also have side effects. Although increasing evidence
      indicates that quercetin supplementation may be beneficial in treating COPD, key
      methodological issues have not been resolved. The overall objective of this study is to
      determine the dosage of quercetin supplementation, bioavailability of quercetin, safety,
      dose-response relationship and appropriate biomarkers which reflect clinical outcomes in
      patients with COPD that is necessary for conducting large clinical trials in this patient
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects diagnosed with mild to moderate COPD (GOLD stage I, II and III)-

          -  10 pack-year smoking history or greater and ceased to smoke at least for 2 months
             prior to recruitment

          -  Subjects taking H2 antagonists, Imodium or loratadine and willing to stop during the
             study period

        Exclusion criteria:

          -  COPD subjects with >80% or <35% predicted

          -  Current smokers

          -  Known allergy/sensitivity to quercetin

          -  Subjects with primary 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

          -  Pregnant or lactating mothers

          -  Women who don't consent to take pregnancy test

          -  Unwillingness to stop flavonoid supplementation

          -  Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by
             Bioflavonoid Food and Supplement Screener

          -  Daily oral steroid treatment, warfarin, cyclosporine (neural, sandimmune), digoxin,
             fexofenadine, paclitaxel, diltiazem, saquinavir, selected chemotherapeutic agents
             (etoposide, vinblastine, vincristine, vindesine), antifungals (ketoconazole,
             itraconazole), protease inhibitors (amprenavir, indinavir, nelfinavir), verapamil,
             oral glucocorticoids, erythromycin, quinidine

          -  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

          -  Child bearing age, who are unwilling to use adequate contraception or abstain during
             the course of the study.