Beneficial Effects of Quercetin in COPD - a Preliminary Clinical Trial
| Status: | Completed |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 3/1/2014 |
| Start Date: | January 2014 |
| End Date: | December 2014 |
| Contact: | Umadevi S Sajjan, PhD |
| Email: | usajjan@med.umich.edu |
| Phone: | 734-936-4200 |
Phase I/II Study to Determine the Safety and Efficacy of Quercetin in COPD
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the U.S.
Current treatment regimens for COPD are only partially effective, expensive, and often not
adhered to by patients. In contrast to standard medications, natural products may have
fewer side effects and be easy and inexpensive to use. Quercetin, a dietary chemical found
in foods such as apples and onions is a natural product with anti-oxidant and
anti-inflammatory properties. Our preliminary data and published studies suggest that
quercetin may be useful in the treatment of COPD. The goal of this proposal is to perform a
pilot study of quercetin in patients with COPD. The information gained from this study,
including the correct dosage of medication and safety profile, will enable researchers to
plan a large clinical trial of quercetin in the future.
Current treatment regimens for COPD are only partially effective, expensive, and often not
adhered to by patients. In contrast to standard medications, natural products may have
fewer side effects and be easy and inexpensive to use. Quercetin, a dietary chemical found
in foods such as apples and onions is a natural product with anti-oxidant and
anti-inflammatory properties. Our preliminary data and published studies suggest that
quercetin may be useful in the treatment of COPD. The goal of this proposal is to perform a
pilot study of quercetin in patients with COPD. The information gained from this study,
including the correct dosage of medication and safety profile, will enable researchers to
plan a large clinical trial of quercetin in the future.
Quercetin, a plant flavonoid widely found in fruits and vegetables, is a potent antioxidant
and anti-inflammatory. We recently showed that daily oral treatment with low levels of
quercetin decreases oxidative stress, inflammation and prevents progression of lung disease
in mice which display typical features of chronic obstructive lung disease (COPD) Our pilot
studies also suggest that quercetin inhibits replication of rhinovirus, a major cause of
COPD exacerbations. Finally, large epidemiological studies have suggested that a
high-quercetin diet decreases the risk of COPD. Together, these data suggest that quercetin
would be beneficial in the treatment of COPD. Nevertheless, key methodologic issues have
not been resolved, including the dosage and frequency of supplementation, bioavailability,
safety, dose-response relationship, or the appropriate biomarkers which reflect clinical
outcomes in this disease. The overall goal of this application is to obtain the information
necessary for large clinical trials in COPD. To accomplish this goal, we propose the
following Specific Aims.
1. Determine if once-daily doses of quercetin are safe, acceptable and reach therapeutic
concentrations in the plasma of patients with COPD. Using a quercetin formulation that
has been "generally recognized as safe" by the FDA (Quercegen Pharma, Sudbury, MA), we
will test the hypotheses that: 1) dietary flavonoid intake can be accurately monitored
by questionnaire; and 2) daily supplementation of quercetin increases plasma quercetin
levels in COPD patients; and 3) quercetin can be administered to patients with COPD of
varying severity without adverse side effects.
2. Determine the effect of quercetin on oxidative stress, lung inflammation and pulmonary
function in patients with COPD. We hypothesize that: 1) oxidative and inflammatory
biomarkers can be safely and accurately measured in the serum and sputum of patients
with COPD; 2) daily treatment with quercetin will reduce plasma and sputum markers of
oxidative stress and inflammation; 3) daily treatment with quercetin will improve
pulmonary function in patients with COPD.
Results from these studies will provide data on the quercetin dosage and biological
endpoints needed to carry out large clinical trials examining the efficacy of quercetin in
COPD.
and anti-inflammatory. We recently showed that daily oral treatment with low levels of
quercetin decreases oxidative stress, inflammation and prevents progression of lung disease
in mice which display typical features of chronic obstructive lung disease (COPD) Our pilot
studies also suggest that quercetin inhibits replication of rhinovirus, a major cause of
COPD exacerbations. Finally, large epidemiological studies have suggested that a
high-quercetin diet decreases the risk of COPD. Together, these data suggest that quercetin
would be beneficial in the treatment of COPD. Nevertheless, key methodologic issues have
not been resolved, including the dosage and frequency of supplementation, bioavailability,
safety, dose-response relationship, or the appropriate biomarkers which reflect clinical
outcomes in this disease. The overall goal of this application is to obtain the information
necessary for large clinical trials in COPD. To accomplish this goal, we propose the
following Specific Aims.
1. Determine if once-daily doses of quercetin are safe, acceptable and reach therapeutic
concentrations in the plasma of patients with COPD. Using a quercetin formulation that
has been "generally recognized as safe" by the FDA (Quercegen Pharma, Sudbury, MA), we
will test the hypotheses that: 1) dietary flavonoid intake can be accurately monitored
by questionnaire; and 2) daily supplementation of quercetin increases plasma quercetin
levels in COPD patients; and 3) quercetin can be administered to patients with COPD of
varying severity without adverse side effects.
2. Determine the effect of quercetin on oxidative stress, lung inflammation and pulmonary
function in patients with COPD. We hypothesize that: 1) oxidative and inflammatory
biomarkers can be safely and accurately measured in the serum and sputum of patients
with COPD; 2) daily treatment with quercetin will reduce plasma and sputum markers of
oxidative stress and inflammation; 3) daily treatment with quercetin will improve
pulmonary function in patients with COPD.
Results from these studies will provide data on the quercetin dosage and biological
endpoints needed to carry out large clinical trials examining the efficacy of quercetin in
COPD.
Inclusion Criteria:
- Male and female COPD patients 40-80 years of age with COPD as defined by
post-bronchodilator forced expiratory volume (FEV)1/Forced vital capacity (FVC) ratio
<0.70 and FEV1% predicted ≥ 35% and ≤80%, have 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 will also be included in the study. Eligible participants who are able to
understand the study procedures, capable of giving informed consent and agree to
comply with the entire duration of the study will be included in the study.
- Women and men with reproductive capability will also be enrolled, however they will
be asked to use contraceptive such as birth control pills for women and condoms for
men or abstain from sexual activity during the study.
Exclusion Criteria:
1. COPD subjects with >80% or <35% predicted
2. Current smokers
3. Known allergy/sensitivity to quercetin
4. Subjects with primary diagnosis of asthma
5. Upper respiratory tract infection within two weeks of the screening visit
6. Acute bacterial infection requiring antibiotics within two weeks of screening
7. Emergency treatment or hospitalization within one month of screening
8. Pregnant or lactating mothers
9. Women who don't consent to take pregnancy test
10. Unwillingness to stop flavonoid supplementation
11. Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by
Bioflavonoid Food and Supplement Screener
12. 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
13. Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) or
loratadine and not willing to stop during study period
14. Lung cancer history or undergoing chemo- or radiation therapy
15. Inflammatory bowel disease
16. Child bearing age, who are unwilling to use adequate contraception or abstain during
the course of the study.
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