CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 9 enrolled
Drug / intervention
Quercetin +1 moredrug
Likely dose
Quercetin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01708278
NCT01708278Phase 1Completed
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Phase I Study to Determine the Safety of Quercetin in COPD Patients

University of Michigan·interventional·Posted Oct 16, 2012·Updated Dec 26, 2016

In Brief

A Phase 1 clinical trial evaluating Quercetin and Placebo - sugar chew for Chronic Obstructive Pulmonary Disease. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), Quercegen Pharmaceuticals, National Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 16, 2012
Enrollment StartFeb 1, 2014
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.7 years ago

Interventions

Quercetindrug

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 1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin 2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin 3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin

Placebo - sugar chewother

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)