Trial Outcomes & Findings for Effect of Symbicort ® on GR in Sputum in COPD (NCT NCT01787097)
NCT ID: NCT01787097
Last Updated: 2020-11-23
Results Overview
Enzyme immunosorbent assay system
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
Screening visit and 2 hours post inhalation of treatment
Results posted on
2020-11-23
Participant Flow
First participant was enrolled January 2013. 4 participants withdrew before randomisation.
Participant milestones
| Measure |
Formoterol 24ug
The first intervention is Formoterol (FORM) total dose 24ug, then Symbicort® total dose 400ug/12ug, then Symbicort® total dose 800ug/24ug, then BUD total dose 800ug
|
Symbicort® Total Dose 400ug/12ug
The first intervention is Symbicort® total dose 400ug/12ug, then Formoterol (FORM) total dose 24ug, then Symbicort® total dose 800ug/24ug, then BUD total dose 800ug
|
Symbicort® Total Dose 800ug/24ug
The first intervention is Symbicort® total dose 800ug/24ug, then Formoterol (FORM) total dose 24ug, then Symbicort® total dose 400ug/12ug, then BUD total dose 800ug
|
BUD Total Dose 800ug
The first intervention is BUD total dose 800ug, then Symbicort® total dose 800ug/24ug, then Formoterol (FORM) total dose 24ug, then Symbicort® total dose 400ug/12ug
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
7
|
9
|
|
Overall Study
COMPLETED
|
7
|
7
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Formoterol 24ug
The first intervention is Formoterol (FORM) total dose 24ug, then Symbicort® total dose 400ug/12ug, then Symbicort® total dose 800ug/24ug, then BUD total dose 800ug
|
Symbicort® Total Dose 400ug/12ug
The first intervention is Symbicort® total dose 400ug/12ug, then Formoterol (FORM) total dose 24ug, then Symbicort® total dose 800ug/24ug, then BUD total dose 800ug
|
Symbicort® Total Dose 800ug/24ug
The first intervention is Symbicort® total dose 800ug/24ug, then Formoterol (FORM) total dose 24ug, then Symbicort® total dose 400ug/12ug, then BUD total dose 800ug
|
BUD Total Dose 800ug
The first intervention is BUD total dose 800ug, then Symbicort® total dose 800ug/24ug, then Formoterol (FORM) total dose 24ug, then Symbicort® total dose 400ug/12ug
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Effect of Symbicort ® on GR in Sputum in COPD
Baseline characteristics by cohort
| Measure |
Symbicort®, Formoterol, Budesonide
n=30 Participants
All Patients will receive randomly one-off dose of the following treatments:
1. Formoterol (FORM) total dose 24ug: is a LABA chosen at a higher clinical dose to determine whether this treatment can achieve an effective treatment response on GR in sputum cells compare to treatments 2 and 3.
2. Symbicort® total dose 400ug/12ug: is a combination of FORM (6ug) and ICS (Budesonide, (BUD) 200ug) at a lower-dose to determine whether this combination can have an effect on GR in sputum cells compare to treatment 4, 1 and 3.
3. Symbicort® total dose 800ug/24ug: is a combination FORM (12ug) and BUD (400ug) at a higher-dose, chosen to compare the effect on GR with treatment 4 and 1
4. BUD total dose 800ug: is an intermediate dose of ICS chosen for comparison with treatments 2 and 3 on GR.
Symbicort®, Formoterol, Budesonide: Formeterol is Long acting beta 2-agonist (LABA) whereas Budesonide is inhaled corticosteroids (ICS).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
30 participants
n=5 Participants
|
|
Pre-bronchodilator FEV1 (% pred.)
|
62 % pred.
n=5 Participants
|
|
Pre-bronchodilator FVC (% pred.)
|
93 % pred.
n=5 Participants
|
|
Sputum CXCL8
|
2.3 ng/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening visit and 2 hours post inhalation of treatmentPopulation: Low patient numbers due to the fact that only a small number of patients were able to produce sputum that was of sufficient quality to undertake analysis, furthermore, sputum production between patient visits was highly variable.
Enzyme immunosorbent assay system
Outcome measures
| Measure |
Formoterol (FORM) Total Dose 24ug
n=5 Participants
Participants received Formoterol (FORM) total dose 24ug
|
Symbicort® Total Dose 400ug/12ug
n=6 Participants
Participants received 2 puffs of a combination of formoterol (6ug) and ICS (Budesonide, (BUD) 200ug)
|
Symbicort® Total Dose 800ug/24ug
n=6 Participants
Participants received 2 puffs of a combination of formoterol (12ug) and budesonide (400ug)
|
Pulmicort 800ug
n=7 Participants
Participants received 2 puffs of Budesoinde 400g (total dose 800ug)
|
|---|---|---|---|---|
|
GR-GRE Binding (Relative to Baseline)
|
1.1 Fold activation
Standard Error 0.1
|
1.8 Fold activation
Standard Error 0.1
|
2.3 Fold activation
Standard Error 0.4
|
2.1 Fold activation
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Screening visit and 2 hours post inhalation of treatmentPopulation: Low patient numbers due to the fact that only a small number of patients were able to produce sputum that was of sufficient quality to undertake analysis, furthermore, sputum production between patient visits was highly variable.
Changes in IL-6 Levels in the sputum supernatant compared to screening visit
Outcome measures
| Measure |
Formoterol (FORM) Total Dose 24ug
n=13 Participants
Participants received Formoterol (FORM) total dose 24ug
|
Symbicort® Total Dose 400ug/12ug
n=13 Participants
Participants received 2 puffs of a combination of formoterol (6ug) and ICS (Budesonide, (BUD) 200ug)
|
Symbicort® Total Dose 800ug/24ug
n=13 Participants
Participants received 2 puffs of a combination of formoterol (12ug) and budesonide (400ug)
|
Pulmicort 800ug
n=12 Participants
Participants received 2 puffs of Budesoinde 400g (total dose 800ug)
|
|---|---|---|---|---|
|
Changes in IL-6 Levels
|
-29 pg/mL
Standard Error 25
|
-14 pg/mL
Standard Error 19
|
-28 pg/mL
Standard Error 22
|
-29 pg/mL
Standard Error 22
|
SECONDARY outcome
Timeframe: Screening visit and 2 hours post inhalation of treatmentPopulation: Low patient numbers due to the fact that only a small number of patients were able to produce sputum that was of sufficient quality to undertake analysis, furthermore, sputum production between patient visits was highly variable.
Changes in CXCL8 concentrations in sputum compared to screening visit.
Outcome measures
| Measure |
Formoterol (FORM) Total Dose 24ug
n=13 Participants
Participants received Formoterol (FORM) total dose 24ug
|
Symbicort® Total Dose 400ug/12ug
n=12 Participants
Participants received 2 puffs of a combination of formoterol (6ug) and ICS (Budesonide, (BUD) 200ug)
|
Symbicort® Total Dose 800ug/24ug
n=12 Participants
Participants received 2 puffs of a combination of formoterol (12ug) and budesonide (400ug)
|
Pulmicort 800ug
n=12 Participants
Participants received 2 puffs of Budesoinde 400g (total dose 800ug)
|
|---|---|---|---|---|
|
Changes in CXCL8 Levels
|
-0.04 ng/mL
Standard Error 0.35
|
-2.1 ng/mL
Standard Error 0.7
|
-2.2 ng/mL
Standard Error 0.55
|
-1.5 ng/mL
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Screening visit and 2 hours post inhalation of treatmentPopulation: Low patient numbers due to the fact that only a small number of patients were able to produce sputum that was of sufficient quality to undertake analysis, furthermore, sputum production between patient visits was highly variable.
Sputum TNF-alpha levels obtained from induced sputum compared to screening visit.
Outcome measures
| Measure |
Formoterol (FORM) Total Dose 24ug
n=13 Participants
Participants received Formoterol (FORM) total dose 24ug
|
Symbicort® Total Dose 400ug/12ug
n=13 Participants
Participants received 2 puffs of a combination of formoterol (6ug) and ICS (Budesonide, (BUD) 200ug)
|
Symbicort® Total Dose 800ug/24ug
n=12 Participants
Participants received 2 puffs of a combination of formoterol (12ug) and budesonide (400ug)
|
Pulmicort 800ug
n=13 Participants
Participants received 2 puffs of Budesoinde 400g (total dose 800ug)
|
|---|---|---|---|---|
|
Changes in TNF Alpha
|
-4.8 pg/mL
Standard Error 9.0
|
-5.7 pg/mL
Standard Error 7.9
|
-7.8 pg/mL
Standard Error 7.3
|
-9.4 pg/mL
Standard Error 7.4
|
SECONDARY outcome
Timeframe: Baseline and 2 hours post inhalationImprovement in FEV1 compared to baseline levels.
Outcome measures
| Measure |
Formoterol (FORM) Total Dose 24ug
n=30 Participants
Participants received Formoterol (FORM) total dose 24ug
|
Symbicort® Total Dose 400ug/12ug
n=30 Participants
Participants received 2 puffs of a combination of formoterol (6ug) and ICS (Budesonide, (BUD) 200ug)
|
Symbicort® Total Dose 800ug/24ug
n=30 Participants
Participants received 2 puffs of a combination of formoterol (12ug) and budesonide (400ug)
|
Pulmicort 800ug
n=30 Participants
Participants received 2 puffs of Budesoinde 400g (total dose 800ug)
|
|---|---|---|---|---|
|
Changes in Lung Function Parameter FEV1
|
160 mL
Standard Error 28
|
120 mL
Standard Error 25
|
200 mL
Standard Error 30
|
52 mL
Standard Error 18
|
Adverse Events
Formoterol 24ug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Symbicort® Total Dose 400ug/12ug:
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Symbicort® Total Dose 800ug/24ug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pulmicort 800ug
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