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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01HL069170-07 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
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Hypotheses: 1) Airway pH regulation is abnormal in severe asthma; 2) In severe asthma, there is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the airways
Specific Aim 1:Test hypothesis that airway pH regulation is abnormal in severe asthma.
1a) Determine the effects of systemic corticosteroids on breath pH in children with severe and mild to moderate asthma.
1b) Examine whether breath condensate pH and other biomarkers of oxidant stress can predict clinical outcomes in children with severe and mild to moderate asthma.
1c) Identify whether increased Th1/Th2 cytokine ratio, and abnormalities in airway glutaminase, G-SNO-reductase, VATPase, and carbonic anhydrase are associated with airway pH disturbance in children with severe asthma.
1d) Test whether rhinovirus infections, which reduce airway pH, persist longer or are more frequent in children with severe asthma than in children with mild to moderate asthma.
1e) Examine the relationship between gastroesophageal reflux and proximal airway pH in children with severe asthma and mild to moderate asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with severe asthma | This group consists of children with severe asthma as defined per ATS workshop criteria (published in 2000). | ||
| Children with non-severe asthma | This group includes children with asthma who do not meet the ATS criteria for severe asthma as outlined in the 2000 workshop report. |
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| Measure | Description | Time Frame |
|---|---|---|
| Exhaled Nitric Oxide at Baseline and Over the Observational Period | Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag | baseline and after 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Breath pH | Breath condensate pH was measured by the RTube (trademark) device. This device is a plastic tube with a one-way exhalation valve and a chilled aluminum sleeve. pH (the log of hydrogen ion concentration) was measured using an Orion pH meter and probe calibrated in 4.0, 7.0, and 10.0 pH solutions. | baseline and 21 days |
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Inclusion Criteria:
Exclusion criteria:
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The study population consists of children with physician-diagnosed asthma in the Atlanta, Georgia area across a wide range of asthma severities (mild, moderate, severe)
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| Name | Affiliation | Role |
|---|---|---|
| W G Teague, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Childrens Center | Atlanta | Georgia | 30322 | United States |
Children with physician diagnosed asthma were enrolled and underwent comprehensive phenotypic characterization consisting of pulmonary function measures, biomarker assessment, and allergy assessment.
Children were recruited from January 2003 to June 2011 from the Emory Children's Center asthma clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Children With Severe Asthma | This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition) |
| FG001 | Children With Non-severe Asthma | This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Children With Asthma | The cohort consists of children with physician-diagnosed asthma across a wide range of severity (mild, moderate, severe) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Exhaled Nitric Oxide at Baseline and Over the Observational Period | Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag | 225 children were enrolled into the study and completed baseline assessments. Only 40 children were followed longitudinally. The results from only those 40 children are shown here. | Posted | Mean | Standard Deviation | parts per billion | baseline and after 21 days |
|
adverse event data were collected for 3 months.
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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 | Children With Severe Asthma | This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Fitzpatrick, Director, Emory Asthma Clinical Research Program | Emory University Department of Pediatrics | 404-727-9112 | anne.fitzpatrick@emory.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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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
|
|
| Secondary | Reduction in Breath pH | Breath condensate pH was measured by the RTube (trademark) device. This device is a plastic tube with a one-way exhalation valve and a chilled aluminum sleeve. pH (the log of hydrogen ion concentration) was measured using an Orion pH meter and probe calibrated in 4.0, 7.0, and 10.0 pH solutions. | 225 children with asthma were enrolled in the study and completed baseline assessments. Only 40 children were followed longitudinally. The data from those 40 children are shown here. | Posted | Mean | Standard Deviation | log of hydrogen ion concentration (pH) | baseline and 21 days |
|
|
|
| 0 |
| 106 |
| 0 |
| 106 |
| EG001 | Children With Non-severe Asthma | This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma. | 0 | 119 | 0 | 119 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |