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Asthma, a chronic disease which produces significant morbidity and mortality in children, is a significant health problem to a large segment of society. Despite considerable advances in the diagnosis and treatment of asthma over the past several years, a sizeable portion of patients do not respond to the "core" treatments. The investigators are now learning that the underlying pathophysiology of disease is different among patients with asthma therefore; treatments which are beneficial in some patient groups may be not achieve affect in other groups.
Antihistamines have been studied in the past for the treatment of asthma. These studies have shown that there may be a beneficial effect of antihistamines in patients with allergic asthma where histamine likely plays a large role in disease and treatment response. However, there is not enough evidence to include these drugs in the standard treatment of asthma.
The investigators hypothesize that histamine plays a definable, significant role in disease pathogenesis and treatment response in children with allergic asthma. The investigators plan to test this overall hypothesis through two specific aims. The first aim will characterize the relative contribution of histamine in allergic vs. non-allergic asthma. This aim will be accomplished by 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Treatment: Levocetirizine(LCT) | Experimental | 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. |
|
| Initial Treatment: Placebo | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levocetirizine 0.5 Mg/mL Oral Solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize Contribution of Histamine in Children With Asthma | 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. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bridgette L. Jones, MD | Children's Mercy Hospital and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital and Clinics | Kansas City | Missouri | 64131 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Laser Doppler Portion Only | Participants who completed Only Laser Doppler portion of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Characterize Contribution of Histamine in Children With Asthma | 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. | 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. | Posted | Mean | Standard Deviation | flux units on a continuous scale | one year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bridgette Jones | Children's Mercy Hospital | 816-302-3811 | bljones@cmh.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C472067 | levocetirizine |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 9 |
| 15 |
| EG001 | 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. 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. | 0 | 13 | 0 | 13 | 6 | 13 |
| EG002 | Laser Doppler Portion Only | Participants who completed Only Laser Doppler portion of the study. | 0 | 183 | 0 | 183 | 0 | 183 |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |