A Phase 1 interventional study of Quercetin and Placebo - sugar chew in Chronic Obstructive Pulmonary Disease, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-26.
Sponsored by University of Michigan · Phase 1, Interventional, and Treatment
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.
In our preclinical study, we have demonstrated that 4 fold increase in plasma quercetin levels significantly decreased lung inflammation and prevented progression. Clinical studies in healthy volunteers 4 fold increase in plasma quercetin levels (0.22 to 1 µM) could be achieved by supplementing with 500mg of quercetin/day. However, safety of quercetin supplementation and quercetin dose required to achieve 4 fold increases in plasma quercetin levels in 'at-high-risk' COPD population is yet to be established. This study involves two phases; the first phase examines the safety of quercetin supplementation in subjects with chronic obstructive pulmonary disease (COPD) and the second phase determines the efficacy of quercetin in COPD patients. In this study, we will enroll COPD patients with mild to moderate disease between the age group of 40 to 65 years. During the first phase, we will enroll a total of 9 patients to examine the tolerance and safety of three doses of quercetin (500, 1000 and 2000 mg/day) in a dose escalation manner. First cohort consisting of three subjects will receive placebo or 500 mg of quercetin per day for one week and the safety of quercetin supplementation will be assessed by monitoring adverse events and any changes in outcomes of blood test that include complete blood counts (CBC)and comprehensive metabolic panel prior to after supplementation. If this dose is safe and tolerated, second cohort of 3 subjects will receive placebo or 1000 mg of quercetin per day quercetin for one week and again safety will be assessed. If the dose is safely tolerated, the third cohort will receive either placebo or 2000 mg of quercetin per day for a week and the safety will be assessed.
Having completed Phase I study at University of Michigan, we planned to do the Phase II efficacy study under separate NCT number. As of 2016 this phase II study has not begun. Based on the initial study, we plan to choose the highest quercetin dose tolerated with no adverse events and the dose (500 mg of quercetin per day) that was found to increase plasma quercetin levels by 4 fold over baseline in healthy volunteers to examine the efficacy of quercetin in reducing inflammatory and oxidative stress markers and improving lung function in COPD subjects. In the second phase, we will enroll a total of 75 subjects and randomized into three arms; placebo (15 subjects) or one of the two doses of quercetin (30 subjects per arm). All enrolled subjects will be asked to avoid quercetin rich foods throughout the study period. One week after enrollment (run-in), subjects will be either supplemented with either placebo or one of the two doses of quercetin for 4 weeks. All participants will be blinded for study agents. Plasma and sputum quercetin levels, lung function, and markers of oxidative stress and inflammation will be determined at the start of the study (following run-in period), at the end of 4 weeks treatment period.
Three of the original outcome measures listed related to this follow up study of 4 weeks treatment which was never begun. Therefore they have been deleted.
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This study's enrollment of 9 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Exclusion criteria:
contains 350 mg of vitamin C and 10 mg niacin
Other: Placebo - sugar chew
Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin
Drug: Quercetin
Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin
Drug: Quercetin
Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin
Drug: Quercetin
contains 350 mg of vitamin C and 10 mg niacin
Other: Placebo - sugar chew
contains 350 mg of vitamin C and 10 mg niacin
Other: Placebo - sugar chew
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
Also known as: QB3C without folic acid
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)
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
Note: If values for any of the measures indicated here were found, the participant would be indicated as a participant with a safety concern, and values for that particular measure would be posted specifically, but since none of the participants experienced these outlying values, results of all tests are expressed here as a composite function. PULMONARY FUNCTION TEST: FEV1% of predicted: decline by \>20% from baseline COMPLETE BLOOD COUNTS: WBC (cells)/mm3 : \<2000, Platelets (cells)/mm3: \<25,000, Hemoglobin (g/dL): \<7.0 COMPREHENSIVE METABOLIC PROFILE (study drug related):Sodium (mmol/L): \<125 or \>148, Potassium (mmol/L): \< 3.0 or \> 6.0, Calcium (mmol/L): \<7.4 or \> 11.5, LIVER FUNCTION TESTS INCREASE BY FACTOR: Enzymes ALT, AST, and Alkaline phosphate, Total bilirubin: for any of these a value \>3X upper limit of normal
Time frame: One week in Phase I safety study
| Milestone | Sugar Chew- Cohort 1 | Quercetin 1-Cohort 1 | Quercetin 2-Cohort 2 | Quercetin 3-Cohort 3 | Sugar Chew-Cohort 2 | Sugar Chew-Cohort 3 |
|---|---|---|---|---|---|---|
| Started | 1 | 2 | 2 | 2 | 1 | 1 |
| Completed | 1 | 2 | 2 | 2 | 1 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Note: If values for any of the measures indicated here were found, the participant would be indicated as a participant with a safety concern, and values for that particular measure would be posted specifically, but since none of the participants experienced these outlying values, results of all tests are expressed here as a composite function. PULMONARY FUNCTION TEST: FEV1% of predicted: decline by \>20% from baseline COMPLETE BLOOD COUNTS: WBC (cells)/mm3 : \<2000, Platelets (cells)/mm3: \<25,000, Hemoglobin (g/dL): \<7.0 COMPREHENSIVE METABOLIC PROFILE (study drug related):Sodium (mmol/L): \<125 or \>148, Potassium (mmol/L): \< 3.0 or \> 6.0, Calcium (mmol/L): \<7.4 or \> 11.5, LIVER FUNCTION TESTS INCREASE BY FACTOR: Enzymes ALT, AST, and Alkaline phosphate, Total bilirubin: for any of these a value \>3X upper limit of normal
| Participants | Sugar Chew- Cohort 1 | Quercetin 1-Cohort 1 | Quercetin 2-Cohort 2 | Quercetin 3-Cohort 3 | Sugar Chew-Cohort 2 | Sugar Chew-Cohort 3 |
|---|---|---|---|---|---|---|
| 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 |
Collected over 14 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sugar Chew-Cohort 1 | — | 0/1 (0%) | 1/1 (100%) |
| Quercetin 1-Cohort 1 | — | 0/2 (0%) | 2/2 (100%) |
| Quercetin 2-Cohort 2 | — | 0/2 (0%) | 2/2 (100%) |
| Quercetin 3-Cohort 3 | — | 0/2 (0%) | 1/2 (50%) |
| Sugar Chew-Cohort 2 | — | 0/1 (0%) | 1/1 (100%) |
| Sugar Chew-Cohort 3 | — | 0/1 (0%) | 1/1 (100%) |
| Event | Sugar Chew-Cohort 1 | Quercetin 1-Cohort 1 | Quercetin 2-Cohort 2 | Quercetin 3-Cohort 3 | Sugar Chew-Cohort 2 | Sugar Chew-Cohort 3 |
|---|---|---|---|---|---|---|
| Heart burn, GERDGastrointestinal disorders | 1/1 | 1/2 | 1/2 | 0/2 | — | 0/1 |
| NauseaGastrointestinal disorders | 0/1 | 0/2 | 0/2 | 0/2 | 0/1 | 1/1 |
| Congestion/Breathlessness/chest tightness/coughRespiratory, thoracic and mediastinal disorders | 1/1 | 2/2 | 1/2 | 1/2 | 1/1 | 1/1 |
| Sleep disturbanceNervous system disorders | 1/1 | 1/2 | 1/2 | 0/2 | 1/1 | 1/1 |
| headache/neck pain/low back painMusculoskeletal and connective tissue disorders | 0/1 | 0/2 | 2/2 | 0/2 | 0/1 | 1/1 |
| AnxietyPsychiatric disorders | 0/1 | 0/2 | 0/2 | 0/2 | 1/1 | 0/1 |
| FluInfections and infestations | 1/1 | 0/2 | 0/2 | 0/2 | 0/1 | 0/1 |
| high glucoseMetabolism and nutrition disorders | 0/1 | 0/2 | 1/2 | 0/2 | 0/1 | 0/1 |
| Age, Customized(participants) | Sugar Chew- Cohort 1 | Quercetin 1-Cohort 1 | Quercetin 2-Cohort 2 | Quercetin 3-Cohort 3 | Sugar Chew-Cohort 2 | Sugar Chew-Cohort 3 | Total |
|---|---|---|---|---|---|---|---|
| Age 40 - 80 years | 1 | 2 | 2 | 2 | 1 | 1 | 9 |
| Gender(Participants) | Sugar Chew- Cohort 1 | Quercetin 1-Cohort 1 | Quercetin 2-Cohort 2 | Quercetin 3-Cohort 3 | Sugar Chew-Cohort 2 | Sugar Chew-Cohort 3 | Total |
|---|---|---|---|---|---|---|---|
| Female | 1 | 1 | 0 | 1 | 1 | 0 | 4 |
| Male | 0 | 1 | 2 | 1 | 0 | 1 | 5 |
| Region of Enrollment(participants) | Sugar Chew- Cohort 1 | Quercetin 1-Cohort 1 | Quercetin 2-Cohort 2 | Quercetin 3-Cohort 3 | Sugar Chew-Cohort 2 | Sugar Chew-Cohort 3 | Total |
|---|---|---|---|---|---|---|---|
| United States | 1 | 2 | 2 | 2 | 1 | 1 | 9 |
| Lung Function(participants) | Sugar Chew- Cohort 1 | Quercetin 1-Cohort 1 | Quercetin 2-Cohort 2 | Quercetin 3-Cohort 3 | Sugar Chew-Cohort 2 | Sugar Chew-Cohort 3 | Total |
|---|---|---|---|---|---|---|---|
| Number | 1 | 2 | 2 | 2 | 1 | 1 | 9 |
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