Trial Outcomes & Findings for Biomarkers of Irritant-Induced and Allergic Asthma (NCT NCT02740543)
NCT ID: NCT02740543
Last Updated: 2021-09-13
Results Overview
The primary outcome is the change in TSLP gene expression in epithelial cells after 2 weeks of treatment of inhaled corticosteroid compared to no treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Baseline and Two (2) weeks
Results posted on
2021-09-13
Participant Flow
Participant milestones
| Measure |
Allergic Asthma (AA)
Fluticasone propionate HFA 220: Subjects will take two (2) puffs of Fluticasone propionate HFA 220 twice a day.
|
Control
No fluticasone propionate HFA was given to participants.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biomarkers of Irritant-Induced and Allergic Asthma
Baseline characteristics by cohort
| Measure |
Allergic Asthma (AA)
n=9 Participants
Fluticasone propionate HFA 220: Subjects will take two (2) puffs of Fluticasone propionate HFA 220 twice a day.
|
Control
n=9 Participants
No fluticasone propionate HFA was given to participants.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 7 • n=99 Participants
|
33 years
STANDARD_DEVIATION 8 • n=107 Participants
|
30 years
STANDARD_DEVIATION 8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
18 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Two (2) weeksThe primary outcome is the change in TSLP gene expression in epithelial cells after 2 weeks of treatment of inhaled corticosteroid compared to no treatment.
Outcome measures
| Measure |
Allergic Asthma (AA)
n=9 Participants
Fluticasone propionate HFA 220: Subjects will take two (2) puffs of Fluticasone propionate HFA 220 twice a day.
|
Control
n=9 Participants
No fluticasone propionate HFA was given to participants.
|
|---|---|---|
|
Change in TSLP Gene Expression
|
0.000197 Fold Change
Standard Deviation 0.000134
|
0.000035 Fold Change
Standard Deviation 0.000023
|
Adverse Events
Allergic Asthma (AA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Angeliki Kazeros, MD
NYU Langone Health - Bellevue Hospital
Phone: 212-263-6479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place