Trial Outcomes & Findings for Association Between Increased Oxidative Stress, Anti-Inflammatory Fatty Acid Formation, and Airway Infection in People With Asthma and Chronic Obstructive Pulmonary Disease (NCT NCT00595114)
NCT ID: NCT00595114
Last Updated: 2016-10-19
Results Overview
8-isoprostane levels in sputum
Recruitment status
COMPLETED
Target enrollment
43 participants
Primary outcome timeframe
Measured at completion of sample analysis
Results posted on
2016-10-19
Participant Flow
Participant milestones
| Measure |
MIA 1
Participants from the MIA trial with mild asthma
|
KIA 1
Participants from the KIA trial with severe asthma
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
19
|
|
Overall Study
COMPLETED
|
24
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Association Between Increased Oxidative Stress, Anti-Inflammatory Fatty Acid Formation, and Airway Infection in People With Asthma and Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
MIA 1
n=24 Participants
Participants from the MIA trial with mild asthma
|
KIA 1
n=19 Participants
Participants from the KIA trial with severe asthma
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 10 • n=5 Participants
|
40 years
STANDARD_DEVIATION 11 • n=7 Participants
|
38 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
19 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at completion of sample analysis8-isoprostane levels in sputum
Outcome measures
| Measure |
MIA 1
n=24 Participants
Participants from the MIA trial with mild asthma
|
KIA 1
n=19 Participants
Participants from the KIA trial with severe asthma
|
|---|---|---|
|
8-isoprostane Levels as Biochemical Markers for Nonenzymatic Oxidative Stress in Asthma
|
292.4 pg/ml
Standard Deviation 51.0
|
421.8 pg/ml
Standard Deviation 195.4
|
Adverse Events
MIA 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
KIA 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place