Chronic Bronchitis With Airway Obstruction, Chronic Obstructive Pulmonary Disease, Emphysema
Conditions
Keywords
COPD, quercetin, polyphenol, mucus, airway obstruction
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 receiving quercetin 1000 mg/day, 8 patients receiving 500 mg/day and 4 subjects receive placebo.
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.
Interventions
DRUGQuercetin 1000 mg
Active comparator
DRUGQuercetin 500 MG
Active comparator
DRUGPlacebo
Placebo comparator
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Quercegen Pharmaceuticals
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomization codes will be generated by a study statistician at the beginning 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.
Intervention model description
Double blinded placebo controlled study
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein (CRP), and surfactant protein (SP)-D in serum | 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 |
| Club cell protein 16 (CC16) pg/ml | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quercetin | six months | Concentration of quercetin in plasma will be determined at baseline and after treatment with study drugs |
Countries
United States
Contacts
Primary ContactUmadevi Sajjan
Outcome results
None listed