Trial Outcomes & Findings for Ginger's Therapeutic Potential in Asthma (NCT NCT03705832)

NCT ID: NCT03705832

Last Updated: 2023-03-27

Results Overview

A methacholine challenge test is a medical test used to assist in the diagnosis of asthma. The patient breathes in nebulized methacholine at gradually increasing doubling doses, starting with diluent only. Methacholine provokes bronchoconstriction, or narrowing of the airways via M3 receptors. The degree of narrowing can then be quantified by spirometry which is performed after inhalation of each dose. Methacholine provocation dose (PD)20 values will be used to measure any change in airway hyperresponsiveness.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 54 participants
• Primary outcome timeframe: Baseline and Day 28
• Results posted on: 2023-03-27

Participant Flow

54 participants were enrolled and 12 participants were excluded due to: lost to follow-up, asthma controlled, lung function below threshold, on exclusionary medications, and not taking asthma medications. Eight participants were withdrawn due to an institutional COVID-19 research pause.

Participant milestones

Measure	Active Drug Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract	Placebo Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo
Overall Study STARTED	21	13
Overall Study COMPLETED	20	12
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Active Drug Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract	Placebo Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Ginger's Therapeutic Potential in Asthma

Baseline characteristics by cohort

Measure	Active Drug n=20 Participants Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract	Placebo n=12 Participants Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo	Total n=32 Participants Total of all reporting groups
Age, Continuous	53.9 years STANDARD_DEVIATION 17.5 • n=93 Participants	56.1 years STANDARD_DEVIATION 13 • n=4 Participants	54.7 years STANDARD_DEVIATION 15.8 • n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	7 Participants n=4 Participants	18 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	5 Participants n=4 Participants	14 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants	3 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) More than one race	4 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment United States	20 participants n=93 Participants	12 participants n=4 Participants	32 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Day 28

Population: Nine active drug and seven placebo participants were analyzed due to: 1) low lung function at the time of the study visit (methacholine testing was withheld for safety reasons) and 2) during the COVID-19 pandemic, methacholine testing was discontinued, as it is an aerosol generating procedure.

A methacholine challenge test is a medical test used to assist in the diagnosis of asthma. The patient breathes in nebulized methacholine at gradually increasing doubling doses, starting with diluent only. Methacholine provokes bronchoconstriction, or narrowing of the airways via M3 receptors. The degree of narrowing can then be quantified by spirometry which is performed after inhalation of each dose. Methacholine provocation dose (PD)20 values will be used to measure any change in airway hyperresponsiveness.

Outcome measures

Measure	Active Drug n=9 Participants Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract	Placebo n=7 Participants Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo
Change in Tolerance to Inhaled Methacholine	5.3 mg/ml Standard Deviation 15.1	24.2 mg/ml Standard Deviation 55.9

PRIMARY outcome

Timeframe: Baseline and Day 56

Population: Twelve active drug and three placebo participants were analyzed due to: 1) low lung function at the time of the study visit (methacholine testing was withheld for safety reasons) and 2) during the COVID-19 pandemic, methacholine testing was discontinued, as it is an aerosol generating procedure.

A methacholine challenge test is a medical test used to assist in the diagnosis of asthma. The patient breathes in nebulized methacholine at gradually increasing doubling doses, starting with diluent only. Methacholine provokes bronchoconstriction, or narrowing of the airways via M3 receptors. The degree of narrowing can then be quantified by spirometry which is performed after inhalation of each dose. Methacholine provocation dose (PD20) values will be used to measure any change in airway hyperresponsiveness.

Outcome measures

Measure	Active Drug n=12 Participants Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract	Placebo n=3 Participants Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo
Change in Tolerance to Inhaled Methacholine	4 PD20 of methacholine (mg/ml) Standard Deviation 13.1	78.4 PD20 of methacholine (mg/ml) Standard Deviation 137.9

PRIMARY outcome

Timeframe: Baseline and Day 28

Population: Eight placebo analyzed due to device malfunction.

Measure of markers of asthmatic lung inflammation

Outcome measures

Measure	Active Drug n=20 Participants Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract	Placebo n=8 Participants Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo
Change in Fractional Exhaled Nitric Oxide (FeNO)	8.5 fractional exhaled parts per billion Standard Deviation 26.9	20.1 fractional exhaled parts per billion Standard Deviation 43.1

PRIMARY outcome

Timeframe: Baseline and Day 56

Population: Nine placebo analyzed due to device malfunction.

Measure of markers of asthmatic lung inflammation

Outcome measures

Measure	Active Drug n=20 Participants Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract	Placebo n=9 Participants Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo
Change in Fractional Exhaled Nitric Oxide (FeNO)	-4.6 fractional exhaled parts per billion Standard Deviation 20.4	26.2 fractional exhaled parts per billion Standard Deviation 62.6

SECONDARY outcome

Timeframe: Baseline and Day 56

Population: Cytokine samples were collected from 15 and 10 active and placebo participants respectively.

Measure of markers of asthmatic lung inflammation

Outcome measures

Measure	Active Drug n=15 Participants Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract	Placebo n=10 Participants Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo
Change in Serum Cytokines	-1.297 pg/ml Standard Deviation 18.81	2.411 pg/ml Standard Deviation 18.81

SECONDARY outcome

Timeframe: Baseline and Day 56

Measure of markers of asthmatic lung inflammation

Outcome measures

Measure	Active Drug n=20 Participants Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract	Placebo n=12 Participants Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo
Change in Eosinophilia	0.007 x10^9 cells/L Standard Deviation 0.219	0.128 x10^9 cells/L Standard Deviation 0.211

SECONDARY outcome

Timeframe: Baseline and Day 56

Asthma symptom score will be measured with the Asthma Control Test at Visit 1, 2 and 5.This instrument, which has been validated for ages 12-84 years, is a 4-week recall questionnaire that addresses issues of asthma control, symptoms, and nocturnal awakenings. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.

Outcome measures

Measure	Active Drug n=20 Participants Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract	Placebo n=12 Participants Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo
Change in Score on the Asthma Control Test (ACT)	-1.6 score on a scale Standard Deviation 3.966	-2.0 score on a scale Standard Deviation 2.045

SECONDARY outcome

Timeframe: Baseline and Day 56

This questionnaire consists of 15 items in 4 domains with a 2-week recall period. Scores range from 7-105, with higher scores indicating better quality of life.

Outcome measures

Measure	Active Drug n=20 Participants Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract	Placebo n=12 Participants Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo
Change In Score on Juniper Mini-Asthma Specific Quality of Life (Mini AQLQ-J)	-11.3 score on a scale Standard Deviation 21.91	-11.5 score on a scale Standard Deviation 13.01

Adverse Events

Active Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active Drug n=20 participants at risk Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract	Placebo n=12 participants at risk Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo
Respiratory, thoracic and mediastinal disorders Coronavirus Disease 2019 (COVID-19)	0.00% 0/20 • Up to Day 78	8.3% 1/12 • Up to Day 78

Other adverse events

Measure	Active Drug n=20 participants at risk Subjects assigned to the intervention will receive 2 grams daily of Ginger Extract for 56 days. Ginger Extract: 2gm Capsule of Ginger extract	Placebo n=12 participants at risk Subjects assigned to the placebo group will receive a matching placebo for 56 days. Placebo: Matching Placebo
Nervous system disorders Absence Seizure	0.00% 0/20 • Up to Day 78	8.3% 1/12 • Up to Day 78

Additional Information

Emily DiMango, MD

Columbia University

Phone: 212-305-0631

Email: ead3@columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place