Trial Outcomes & Findings for Pharmacokinetics of Inhaled Monodisperse Fluticasone Propionate (NCT NCT00692978)
NCT ID: NCT00692978
Last Updated: 2020-11-25
Results Overview
The main outcome measure is the concentration of Fluticasone Propionate in blood following inhalation of the dose. This will be found by calculating the area under the curve of concentration versus time 0 and 12 hours.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
12 hours
Results posted on
2020-11-25
Participant Flow
Participant milestones
| Measure |
Asthma Patients
Monodisperse aerosols (MO) inhaled of Fluticasone Propionate (FP) 50micrograms dose
|
Healthy Volunteers
Monodisperse aerosols (MO) inhaled of Fluticasone Propionate (FP) 50micrograms dose
|
|---|---|---|
|
FP From Active 250 ug MDI Inhaler
STARTED
|
15
|
15
|
|
FP From Active 250 ug MDI Inhaler
COMPLETED
|
15
|
15
|
|
FP From Active 250 ug MDI Inhaler
NOT COMPLETED
|
0
|
0
|
|
FP1.5 Microns Size With MDI Inhaler
STARTED
|
15
|
15
|
|
FP1.5 Microns Size With MDI Inhaler
COMPLETED
|
15
|
15
|
|
FP1.5 Microns Size With MDI Inhaler
NOT COMPLETED
|
0
|
0
|
|
FP 3 Microns Size With MDI Inhaler
STARTED
|
15
|
15
|
|
FP 3 Microns Size With MDI Inhaler
COMPLETED
|
15
|
15
|
|
FP 3 Microns Size With MDI Inhaler
NOT COMPLETED
|
0
|
0
|
|
FP 6 Microns Size With MDI Inhaler
STARTED
|
15
|
15
|
|
FP 6 Microns Size With MDI Inhaler
COMPLETED
|
15
|
15
|
|
FP 6 Microns Size With MDI Inhaler
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 |
Asthma Patients
n=15 Participants
Recruited Asthma patients
|
Healthy Volunteers
n=15 Participants
Recruited healthy volunteers
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 11.8 • n=15 Participants
|
35 years
STANDARD_DEVIATION 10.5 • n=15 Participants
|
35 years
STANDARD_DEVIATION 11 • n=30 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=15 Participants
|
10 Participants
n=15 Participants
|
17 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
13 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 12 hoursThe main outcome measure is the concentration of Fluticasone Propionate in blood following inhalation of the dose. This will be found by calculating the area under the curve of concentration versus time 0 and 12 hours.
Outcome measures
| Measure |
FP From Active 250 ug MDI Inhaler Asthma
n=15 Participants
Monodisperse aerosols inhaled of Fluticasone Propionate at 250micrograms dose with active MDI inhaler with Asthma participants
|
FP 50ug 1.5um Asthma
n=15 Participants
Monodisperse aerosols inhaled of Fluticasone Propionate 1.5 microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Asthma patients
|
FP 50ug 3um Asthma
n=15 Participants
Monodisperse aerosols inhaled of Fluticasone Propionate 3 microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Asthma patients
|
FP 50ug 6um Asthma
n=15 Participants
Monodisperse aerosols inhaled of Fluticasone Propionate 6 microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Asthma patients
|
FP From Active 250 ug MDI Inhaler HV
n=15 Participants
Monodisperse aerosols inhaled of Fluticasone Propionate at 250micrograms dose with active MDI inhaler with Healthy participants
|
FP 50ug 1.5um HV
n=15 Participants
Monodisperse aerosols inhaled of Fluticasone Propionate 1.5microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Healthy volunteers
|
FP 50ug 3um HV
n=15 Participants
Monodisperse aerosols inhaled of Fluticasone Propionate 3microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Healthy volunteers
|
FP 50ug 6um HV
n=15 Participants
Monodisperse aerosols inhaled of Fluticasone Propionate 3microns size at 50micrograms dose with double-dummy placebo MDI inhaler with Healthy volunteers
|
|---|---|---|---|---|---|---|---|---|
|
AUC Fluticasone Propionate (FP)
|
188.2 pg.h/ml
Interval 46.13 to 594.89
|
756 pg.h/ml
Interval 613.0 to 2967.0
|
978 pg.h/ml
Interval 413.8 to 2610.4
|
380.5 pg.h/ml
Interval 2.2 to 1586.1
|
172.3 pg.h/ml
Interval 34.4 to 778.41
|
740 pg.h/ml
Interval 332.0 to 2421.0
|
934.6 pg.h/ml
Interval 478.0 to 2647.7
|
250.4 pg.h/ml
Interval 26.9 to 740.8
|
Adverse Events
FP From Active 250 ug MDI Inhaler Asthma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FP 50ug 1.5um Asthma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FP 50ug 3um Asthma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FP 50ug 6um Asthma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FP From Active 250 ug MDI Inhaler Healthy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FP 50ug 1.5um Healthy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FP 50ug 3um Healthy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FP 50ug 6um Healthy
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