Trial Outcomes & Findings for p38 Mitogen-Activated Protein Kinase (MAPK) and Steroid Insensitivity in Asthma (NCT NCT00676572)
NCT ID: NCT00676572
Last Updated: 2019-10-15
Results Overview
Recruitment status
COMPLETED
Target enrollment
12 participants
Primary outcome timeframe
3 years
Results posted on
2019-10-15
Participant Flow
Participant milestones
| Measure |
Severe Asthma
Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
|
Non-severe Asthma
Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Severe Asthma
n=6 Participants
Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
|
Non-severe Asthma
n=6 Participants
Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 2.67 • n=6 Participants
|
32.8 years
STANDARD_DEVIATION 3.88 • n=6 Participants
|
39.9 years
STANDARD_DEVIATION 3.27 • n=12 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
8 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Data no collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPercentage of Suppression of IL6 release by p38 MAPK inhibitor
Outcome measures
| Measure |
Severe Asthma
n=6 Participants
Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
|
Non-severe Asthma
n=6 Participants
Fiberoptic bronchoscopy; blood test: Fiberoptic bronchoscopy for obtention of alveolar macrophages and bronchial biopsies for histology and culture of airway smooth muscle cells
|
|---|---|---|
|
Differences in the Effect of p38 MAPK Inhibitor in Dexamethasone-Inhibition of Cytokine Release From Alveolar Macrophages and PBMCs Between Severe and Non-Severe Asthmatics
|
50 percentage of suppression of IL6 release
Standard Error 20
|
8 percentage of suppression of IL6 release
Standard Error 10
|
Adverse Events
Severe Asthma
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
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