Trial Outcomes & Findings for Characterization of the Role of Histamine in Children With Asthma (NCT NCT01392859)

Last Updated: 2021-08-30

Results Overview

The investigators will compare the response to histamine via histamine iontophoresis with laser doppler monitoring (measured in flux units on a continuous scale)between subjects with allergic asthma compared to subjects with non-allergic asthma.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

211 participants

Primary outcome timeframe

one year

Results posted on

2021-08-30

Participant Flow

211 total participants enrolled in the study including the laser doppler testing. Only a small sub-set (n=28) of these participants were included in the sub-study including Levocetirizine.

Participant milestones

Participant milestones
Measure	Initial Treatment: Levocetirizine First, Then Placebo Only a small sub-set of the overall study participants were included in this analysis. Group 1 will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days. These participants also went through the laser doppler portion prior to the crossover portion of the study. Levocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.	Initial Treatment: Placebo First, Then Levocetirizine Only a small sub-set of the overall study participants were included in this analysis. Group 2 will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days. These participants also went through the laser doppler portion prior to the crossover portion of the study. Levocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.	Laser Doppler Portion Only Participants who completed Only Laser Doppler portion of the study.
Overall Study STARTED	15	13	183
Overall Study Wash Out 3-7 Days	15	13	0
Overall Study COMPLETED	13	13	183
Overall Study NOT COMPLETED	2	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Characterization of the Role of Histamine in Children With Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=211 Participants 211 participants enrolled in overall study including laser doppler testing. Only 28 participants continued to subgroups below: Group 1: Initial Treatment: Levocetirizine(LCT) will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days. Levocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD. Group 2: Initial Treatment: Placebo will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days. Levocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.
Age, Continuous	12.1 Years STANDARD_DEVIATION 3.1 • n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants
Sex: Female, Male Male	121 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	74 Participants n=5 Participants
Race (NIH/OMB) White	115 Participants n=5 Participants
Race (NIH/OMB) More than one race	17 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	211 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Population: Participants have been stratified based on their reactivity (i.e., participants with hyper-, normo-, or hypo-reactivity) and therefore the Number Analyzed for each Row differs from the Overall Number of Participants Analyzed.

Outcome measures

Outcome measures
Measure	Overall Study n=211 Participants Comparison of the microvasculature response to histamine in children with allergic asthma and children with non-allergic asthma, measured by histamine iontophoresis with laser Doppler (HILD) monitoring, to determine potential phenotype-associated differences in the pharmacodynamic response to histamine.
Characterize Contribution of Histamine in Children With Asthma Hyper-Reactive-	11253.24 flux units on a continuous scale Standard Deviation 4271.17
Characterize Contribution of Histamine in Children With Asthma Normo-Reactive	6464.20 flux units on a continuous scale Standard Deviation 1048.63
Characterize Contribution of Histamine in Children With Asthma Hypo-Reactive	3539.67 flux units on a continuous scale Standard Deviation 1239.95

Adverse Events

Initial Treatment: Levocetirizine First, Then Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Initial Treatment: Placebo First, Then Levocetirizine

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Laser Doppler Portion Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Initial Treatment: Levocetirizine First, Then Placebo n=15 participants at risk Only a small sub-set of the overall study participants were included in this analysis. Group 1 will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days. Levocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD. These participants also went through the laser doppler portion prior to the crossover portion of the study. Note: Adverse Events (AE) were recorded by arm therefore AE's cannot be provided for each intervention separately. This data is no longer available to retrospectively separate AE's out by intervention.	Initial Treatment: Placebo First, Then Levocetirizine n=13 participants at risk Only a small sub-set of the overall study participants were included in this analysis. Group 2 will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days. Levocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD. These participants also went through the laser doppler portion prior to the crossover portion of the study. Note: Adverse Events (AE) were recorded by arm therefore AE's cannot be provided for each intervention separately. This data is no longer available to retrospectively separate AE's out by intervention.	Laser Doppler Portion Only n=183 participants at risk Participants who completed Only Laser Doppler portion of the study.
Gastrointestinal disorders Diarrhea	6.7% 1/15 • Number of events 1	7.7% 1/13 • Number of events 1	0.00% 0/183
Nervous system disorders Syncope	13.3% 2/15 • Number of events 2	7.7% 1/13 • Number of events 1	0.00% 0/183
Metabolism and nutrition disorders Hyperglycemia	6.7% 1/15 • Number of events 1	0.00% 0/13	0.00% 0/183
Nervous system disorders Headache	6.7% 1/15 • Number of events 1	15.4% 2/13 • Number of events 2	0.00% 0/183
Cardiac disorders Chest Pain	6.7% 1/15 • Number of events 1	0.00% 0/13	0.00% 0/183
Gastrointestinal disorders Nausea	20.0% 3/15 • Number of events 3	15.4% 2/13 • Number of events 2	0.00% 0/183

Additional Information

Dr. Bridgette Jones

Children's Mercy Hospital

Phone: 816-302-3811

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place