Trial Outcomes & Findings for Beneficial Effects of Quercetin in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01708278)

Last Updated: 2016-12-26

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

9 participants

Primary outcome timeframe

One week in Phase I safety study

Results posted on

2016-12-26

Participant Flow

Participant milestones

Participant milestones
Measure	Sugar Chew- Cohort 1 contains 350 mg of vitamin C and 10 mg niacin Placebo - sugar chew: 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)	Quercetin 1-Cohort 1 Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin Quercetin: 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	Quercetin 2-Cohort 2 Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin Quercetin: 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	Quercetin 3-Cohort 3 Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin Quercetin: 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	Sugar Chew-Cohort 2 contains 350 mg of vitamin C and 10 mg niacin Placebo - sugar chew: 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)	Sugar Chew-Cohort 3 contains 350 mg of vitamin C and 10 mg niacin Placebo - sugar chew: 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)
Overall Study STARTED	1	2	2	2	1	1
Overall Study COMPLETED	1	2	2	2	1	1
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Beneficial Effects of Quercetin in Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugar Chew- Cohort 1 n=1 Participants contains 350 mg of vitamin C and 10 mg niacin Placebo - sugar chew: 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)	Quercetin 1-Cohort 1 n=2 Participants Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin Quercetin: 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	Quercetin 2-Cohort 2 n=2 Participants Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin Quercetin: 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	Quercetin 3-Cohort 3 n=2 Participants Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin Quercetin: 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	Sugar Chew-Cohort 2 n=1 Participants contains 350 mg of vitamin C and 10 mg niacin Placebo - sugar chew: 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)	Sugar Chew-Cohort 3 n=1 Participants contains 350 mg of vitamin C and 10 mg niacin Placebo - sugar chew: 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)	Total n=9 Participants Total of all reporting groups
Age, Customized Age 40 - 80 years	1 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants	1 participants n=21 Participants	1 participants n=8 Participants	9 participants n=8 Participants
Gender Female	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Gender Male	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants
Region of Enrollment United States	1 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants	1 participants n=21 Participants	1 participants n=8 Participants	9 participants n=8 Participants
Lung Function	1 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants	1 participants n=21 Participants	1 participants n=8 Participants	9 participants n=8 Participants

PRIMARY outcome

Timeframe: One week in Phase I safety study