Trial Outcomes & Findings for Effect of Symbicort on GR Localisation in Asthma (NCT NCT00159263)
NCT ID: NCT00159263
Last Updated: 2019-09-27
Results Overview
The GR-GRE binding is the glucocorticoid receptor (GR) DNA binding affinity. GR-GRE activity as assed by enzyme-immunosorbent assay
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
1-2h
Results posted on
2019-09-27
Participant Flow
10patient recruited mild asthma
Participant milestones
| Measure |
Formoterol
First intervention is formoterol, then placebo, then Budesonide low dose, then Budesonide high dose, then Budesonide/Formoterol single, then Budesonide/Formoterol double
|
Budesonide Low Dose
First intervention is Budesonide low dose, then placebo, then Formoterol, then Budesonide high dose, then Budesonide/Formoterol single, then Budesonide/Formoterol double
|
Budesonide High Dose
First intervention is Budesonide high dose, then placebo, then Formoterol, then Budesonide low dose, then Budesonide/Formoterol single, then Budesonide/Formoterol double
|
Budesonide/Formoterol Single
First intervention is Budesonide/Formoterol single, then placebo, then Formoterol, then Budesonide low dose, then Budesonide high dose, then Budesonide/Formoterol double
|
Budesonide/Formoterol Double
First intervention is Budesonide/Formoterol double, then placebo, then Formoterol, then Budesonide low dose, then Budesonide high dose, then Budesonide/Formoterol single
|
Placebo
first intervention is placebo, then Formoterol, then Budesonide low dose, then Budesonide high dose, then Budesonide/Formoterol single, then Budesonide/Formoterol double
|
|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
First Intervention
COMPLETED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout
STARTED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Washout
COMPLETED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Washout
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Second Intervention
COMPLETED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Third Intervention
COMPLETED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fourth Intervention
STARTED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Fourth Intervention
COMPLETED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Fourth Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fifth Intervention
STARTED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Fifth Intervention
COMPLETED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Fifth Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Sixth Intervention
STARTED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Sixth Intervention
COMPLETED
|
1
|
2
|
2
|
2
|
2
|
1
|
|
Sixth Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
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 |
Overall Study
n=10 Participants
Crossover study, same volunteers in all arm, received the following interventions: formoterol, Budesonide low and high dose, or combination of these
|
|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 3 • n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 1-2hPopulation: Crossover, each patient had all treatments
The GR-GRE binding is the glucocorticoid receptor (GR) DNA binding affinity. GR-GRE activity as assed by enzyme-immunosorbent assay
Outcome measures
| Measure |
Placebo
n=10 Participants
placebo
Placebos: Dry powder inhaler
|
Formoterol
n=10 Participants
Oxis(®) 12 μg
Formoterol Inhalant Powder: 12ug
|
Budesonide Low Dose
n=10 Participants
Pulmicort(®) 200 μg
Budesonide Powder: Inhaler
|
Budesonide High Dose
n=10 Participants
Pulmicort(®) 800 μg
Budesonide Powder: Inhaler
|
Budesonide/Formoterol Combination Single
n=10 Participants
single 100/6 μg SYM100
Budesonide and Formoterol Product: Combination Inhaler, Symbicort
|
Budesonide/Formoterol Combination Double
n=10 Participants
double 200/12 μg SYM200
Budesonide and Formoterol Product: Combination Inhaler, Symbicort
|
|---|---|---|---|---|---|---|
|
Changes in GR-GRE Binding
|
1.4 GRE activity (OD)
Interval 0.5 to 2.0
|
1.4 GRE activity (OD)
Interval 0.3 to 2.6
|
1.6 GRE activity (OD)
Interval 0.7 to 2.0
|
2.3 GRE activity (OD)
Interval 1.1 to 7.0
|
3.5 GRE activity (OD)
Interval 1.3 to 6.1
|
3 GRE activity (OD)
Interval 1.5 to 6.0
|
PRIMARY outcome
Timeframe: 1-2hChanges in MKP-1 mRNA measured by PCR
Outcome measures
| Measure |
Placebo
n=10 Participants
placebo
Placebos: Dry powder inhaler
|
Formoterol
n=10 Participants
Oxis(®) 12 μg
Formoterol Inhalant Powder: 12ug
|
Budesonide Low Dose
n=10 Participants
Pulmicort(®) 200 μg
Budesonide Powder: Inhaler
|
Budesonide High Dose
n=10 Participants
Pulmicort(®) 800 μg
Budesonide Powder: Inhaler
|
Budesonide/Formoterol Combination Single
n=10 Participants
single 100/6 μg SYM100
Budesonide and Formoterol Product: Combination Inhaler, Symbicort
|
Budesonide/Formoterol Combination Double
n=10 Participants
double 200/12 μg SYM200
Budesonide and Formoterol Product: Combination Inhaler, Symbicort
|
|---|---|---|---|---|---|---|
|
Changes in MKP-1 mRNA
|
1 MKP1/GNB2L1 ratio
Interval 0.1 to 1.0
|
3 MKP1/GNB2L1 ratio
Interval 1.0 to 44.0
|
3 MKP1/GNB2L1 ratio
Interval 2.0 to 70.0
|
4 MKP1/GNB2L1 ratio
Interval 4.0 to 51.0
|
5 MKP1/GNB2L1 ratio
Interval 3.0 to 150.0
|
5 MKP1/GNB2L1 ratio
Interval 3.0 to 150.0
|
PRIMARY outcome
Timeframe: 1-2hMeasured by PCR
Outcome measures
| Measure |
Placebo
n=10 Participants
placebo
Placebos: Dry powder inhaler
|
Formoterol
n=10 Participants
Oxis(®) 12 μg
Formoterol Inhalant Powder: 12ug
|
Budesonide Low Dose
n=10 Participants
Pulmicort(®) 200 μg
Budesonide Powder: Inhaler
|
Budesonide High Dose
n=10 Participants
Pulmicort(®) 800 μg
Budesonide Powder: Inhaler
|
Budesonide/Formoterol Combination Single
n=10 Participants
single 100/6 μg SYM100
Budesonide and Formoterol Product: Combination Inhaler, Symbicort
|
Budesonide/Formoterol Combination Double
n=10 Participants
double 200/12 μg SYM200
Budesonide and Formoterol Product: Combination Inhaler, Symbicort
|
|---|---|---|---|---|---|---|
|
IL8 mRNA
|
1 IL8/GNB2L1 ratio
Interval 0.1 to 1.7
|
4 IL8/GNB2L1 ratio
Interval 0.1 to 20.0
|
4 IL8/GNB2L1 ratio
Interval 0.1 to 20.0
|
0.4 IL8/GNB2L1 ratio
Interval 0.1 to 1.3
|
0.2 IL8/GNB2L1 ratio
Interval 0.1 to 0.7
|
0.2 IL8/GNB2L1 ratio
Interval 0.1 to 1.4
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Formoterol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Budesonide Low Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Budesonide High Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Budesonide/Formoterol Single
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Budesonide/Formoterol Double
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