Trial Outcomes & Findings for Airway Smooth Muscle and Asthma Severity (NCT NCT00779870)
NCT ID: NCT00779870
Last Updated: 2019-10-31
Results Overview
Recruitment status
COMPLETED
Target enrollment
18 participants
Primary outcome timeframe
at time of bronchoscopy, an average of 1 hour
Results posted on
2019-10-31
Participant Flow
Results of the low number of participants the mild and moderate asthma patients were combined to Non severe group
Participant milestones
| Measure |
Healthy
Healthy Participant
|
Non-severe Asthma
Patients with mild and moderate asthma
|
Severe Asthma
Patients with severe asthma
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
7
|
|
Overall Study
COMPLETED
|
5
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing data from participant
Baseline characteristics by cohort
| Measure |
Healthy
n=5 Participants
Healthy Participant
|
Non-severe Asthma
n=6 Participants
Patients with mild and moderate asthma
|
Severe Asthma
n=7 Participants
Patients with severe asthma
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.67 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
38.17 years
STANDARD_DEVIATION 8.5 • n=6 Participants
|
36.67 years
STANDARD_DEVIATION 4.12 • n=7 Participants
|
36.5 years
STANDARD_DEVIATION 6.3 • n=18 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants • Missing data from participant
|
1 Participants
n=6 Participants • Missing data from participant
|
2 Participants
n=6 Participants • Missing data from participant
|
4 Participants
n=15 Participants • Missing data from participant
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants • Missing data from participant
|
5 Participants
n=6 Participants • Missing data from participant
|
4 Participants
n=6 Participants • Missing data from participant
|
11 Participants
n=15 Participants • Missing data from participant
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
6 participants
n=6 Participants
|
7 participants
n=7 Participants
|
18 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: at time of bronchoscopy, an average of 1 hourPopulation: No data collected
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: at time of bronchoscopy, an average of 1 hourPopulation: Data not collected
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: at time of bronchoscopy, an average of 1 hourExpression of Nrf2 protein
Outcome measures
| Measure |
Healthy
n=5 Participants
Healthy Participant
|
Non-severe Asthma
n=6 Participants
Patients with mild and moderate asthma
|
Severe Asthma
n=7 Participants
Patients with severe asthma
|
|---|---|---|---|
|
Difference in Intracellular Oxidative Stress Mechanisms From ASM Between Groups
|
2 relative expression unit
Interval 1.1 to 2.4
|
3 relative expression unit
Interval 1.1 to 3.6
|
3 relative expression unit
Interval 1.2 to 4.2
|
SECONDARY outcome
Timeframe: at the time of bronchoscopy, an average of 1 hourPopulation: No data collected
Outcome measures
Outcome data not reported
Adverse Events
Healthy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-severe Asthma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Severe Asthma
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