An observational study in Asthma, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 6 Years to 21 Years. Per ClinicalTrials.gov, last updated 2014-02-10.
Sponsored by Emory University · Observational
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 225 is above the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion criteria:
This group consists of children with severe asthma as defined per ATS workshop criteria (published in 2000).
This group includes children with asthma who do not meet the ATS criteria for severe asthma as outlined in the 2000 workshop report.
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
Time frame: baseline and after 21 days
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.
Time frame: baseline and 21 days
Children were recruited from January 2003 to June 2011 from the Emory Children's Center asthma clinic.
| Milestone | Children With Severe Asthma | Children With Non-severe Asthma |
|---|---|---|
| Started | 106 | 119 |
| Completed | 106 | 119 |
| Not completed | 0 | 0 |
Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag
| parts per billion | Children With Severe Asthma | Children With Non-severe Asthma |
|---|---|---|
| Exhaled nitric oxide value at 21 days | 15.1 ± 5.4 | 9.9 ± 5.8 |
| Exhaled nitric oxide baseline value | 13.7 ± 7.4 | 8.6 ± 6.2 |
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.
| log of hydrogen ion concentration (pH) | Children With Severe Asthma | Children With Non-severe Asthma |
|---|---|---|
| Breath pH at 21 days | 7.08 ± 0.52 | 7.58 ± 0.32 |
| Breath pH at baseline | 7.68 ± 0.69 | 7.63 ± 0.88 |
Collected over adverse event data were collected for 3 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Children With Severe Asthma | — | 0/106 (0%) | 0/106 (0%) |
| Children With Non-severe Asthma | — | 0/119 (0%) | 0/119 (0%) |
| Age, Categorical(Participants) | Children With Asthma |
|---|---|
| <=18 years | 225 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Children With Asthma |
|---|---|
| Mean | 11.8 ± 3.6 |
| Sex: Female, Male(Participants) | Children With Asthma |
|---|---|
| Female | 102 |
| Male | 123 |
| Region of Enrollment(participants) | Children With Asthma |
|---|---|
| United States | 225 |
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Emory University