Phase 1
N=9
Beneficial Effects of Quercetin in Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT01708278 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Participants Who Experienced Safety Concerns, Where Safety Concerns of Quercetin Supplementation is Indicated by Significant Change From Baseline Measures of Tests Indicated Below in Outcome Measure Description — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Quercetin (Drug); Placebo - sugar chew (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Experienced Safety Concerns, Where Safety Concerns of Quercetin Supplementation is Indicated by Significant Change From Baseline Measures of Tests Indicated Below in Outcome Measure Description |
0; 0; 0; 0; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01708278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.