Trial Outcomes & Findings for Redox Determinants of Severe Asthma (a Substudy of the Severe Asthma Research Program) (NCT NCT00590005)
NCT ID: NCT00590005
Last Updated: 2014-02-10
Results Overview
Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag
COMPLETED
225 participants
baseline and after 21 days
2014-02-10
Participant Flow
Children were recruited from January 2003 to June 2011 from the Emory Children's Center asthma clinic.
Children with physician diagnosed asthma were enrolled and underwent comprehensive phenotypic characterization consisting of pulmonary function measures, biomarker assessment, and allergy assessment.
Participant milestones
| Measure |
Children With Severe Asthma
This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
|
Children With Non-severe Asthma
This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
119
|
|
Overall Study
COMPLETED
|
106
|
119
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Redox Determinants of Severe Asthma (a Substudy of the Severe Asthma Research Program)
Baseline characteristics by cohort
| Measure |
Children With Asthma
n=225 Participants
The cohort consists of children with physician-diagnosed asthma across a wide range of severity (mild, moderate, severe)
|
|---|---|
|
Age, Categorical
<=18 years
|
225 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
11.8 years
STANDARD_DEVIATION 3.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
225 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: baseline and after 21 daysPopulation: 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.
Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag
Outcome measures
| Measure |
Children With Severe Asthma
n=20 Participants
This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
|
Children With Non-severe Asthma
n=20 Participants
This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
|
|---|---|---|
|
Exhaled Nitric Oxide at Baseline and Over the Observational Period
Exhaled nitric oxide value at 21 days
|
15.1 parts per billion
Standard Deviation 5.4
|
9.9 parts per billion
Standard Deviation 5.8
|
|
Exhaled Nitric Oxide at Baseline and Over the Observational Period
Exhaled nitric oxide baseline value
|
13.7 parts per billion
Standard Deviation 7.4
|
8.6 parts per billion
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: baseline and 21 daysPopulation: 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.
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.
Outcome measures
| Measure |
Children With Severe Asthma
n=20 Participants
This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
|
Children With Non-severe Asthma
n=20 Participants
This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
|
|---|---|---|
|
Reduction in Breath pH
Breath pH at 21 days
|
7.08 log of hydrogen ion concentration (pH)
Standard Deviation 0.52
|
7.58 log of hydrogen ion concentration (pH)
Standard Deviation 0.32
|
|
Reduction in Breath pH
Breath pH at baseline
|
7.68 log of hydrogen ion concentration (pH)
Standard Deviation 0.69
|
7.63 log of hydrogen ion concentration (pH)
Standard Deviation 0.88
|
Adverse Events
Children With Severe Asthma
Children With Non-severe Asthma
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Anne Fitzpatrick, Director, Emory Asthma Clinical Research Program
Emory University Department of Pediatrics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place