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Trial Outcomes & Findings for Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma (NCT NCT00536913)

NCT ID: NCT00536913

Last Updated: 2012-04-06

Results Overview

Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

107 participants

Primary outcome timeframe

At baseline and 4 weeks

Results posted on

2012-04-06

Participant Flow

137 subjects enrolled; 30 non randomised: 26 failed inclusion criteria, 2 voluntary discontinuations, 1 incorrect enrolment, 1 adverse event. 107 subjects were randomised

Participant milestones

Participant milestones
Measure
With Spacer
Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer
Budesonide/formoterol pMDI 40/2.25 ug
Overall Study
STARTED
55
52
Overall Study
COMPLETED
55
52
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
With Spacer
n=55 Participants
Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer
n=52 Participants
Budesonide/formoterol pMDI 40/2.25 ug
Total
n=107 Participants
Total of all reporting groups
Age Continuous
8.6 years
n=5 Participants
8.9 years
n=7 Participants
8.7 years
n=5 Participants
Sex: Female, Male
Female
21 Participants
n=5 Participants
22 Participants
n=7 Participants
43 Participants
n=5 Participants
Sex: Female, Male
Male
34 Participants
n=5 Participants
30 Participants
n=7 Participants
64 Participants
n=5 Participants

PRIMARY outcome

Timeframe: At baseline and 4 weeks

Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment

Outcome measures

Outcome measures
Measure
With Spacer
n=54 Participants
Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer
n=51 Participants
Budesonide/formoterol pMDI 40/2.25 ug
Urinary Free Cortisol (UFC)
0.86 Ratio
Interval 0.2 to 2.4
1.03 Ratio
Interval 0.12 to 5.4

SECONDARY outcome

Timeframe: At baseline, at 2 weeks and 4 weeks

Changes in FEV1 from baseline to the mean value at 2 weeks to 4 weeks with the baseline value as a covariate.

Outcome measures

Outcome measures
Measure
With Spacer
n=55 Participants
Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer
n=52 Participants
Budesonide/formoterol pMDI 40/2.25 ug
Forced Expiratory Volume in 1 Second (FEV1)
0.17 Liters
Full Range -0.38 • Interval -0.38 to 0.76
0.14 Liters
Full Range -0.34 • Interval -0.34 to 0.82

SECONDARY outcome

Timeframe: Daily during run-in and daily during treatment period of 6 weeks

Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry were estimated using linear interpolation.

Outcome measures

Outcome measures
Measure
With Spacer
n=55 Participants
Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer
n=52 Participants
Budesonide/formoterol pMDI 40/2.25 ug
Morning Peak Expiratory Flow (mPEF)
28.70 Liters/min
Standard Deviation 24.6
19.50 Liters/min
Standard Deviation 25.1

SECONDARY outcome

Timeframe: Daily during run-in and daily during treatment period of 6 weeks

Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation. Missing data between the first and last entry were estimated using linear interpolation.

Outcome measures

Outcome measures
Measure
With Spacer
n=55 Participants
Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer
n=52 Participants
Budesonide/formoterol pMDI 40/2.25 ug
Evening Peak Expiratory Flow (ePEF)
27.00 Liters/min
Standard Deviation 27.7
15.30 Liters/min
Standard Deviation 23.0

SECONDARY outcome

Timeframe: Daily during run-in and daily during treatment period of 6 weeks

Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.

Outcome measures

Outcome measures
Measure
With Spacer
n=55 Participants
Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer
n=52 Participants
Budesonide/formoterol pMDI 40/2.25 ug
Asthma Symptoms at Night
-0.20 Units on a scale
Standard Deviation 0.46
-0.21 Units on a scale
Standard Deviation 0.39

SECONDARY outcome

Timeframe: Daily during run-in and daily during treatment period of 6 weeks

Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.

Outcome measures

Outcome measures
Measure
With Spacer
n=55 Participants
Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer
n=52 Participants
Budesonide/formoterol pMDI 40/2.25 ug
Asthma Symptoms at Day
-0.25 Units on a scale
Standard Deviation 0.43
-0.28 Units on a scale
Standard Deviation 0.41

SECONDARY outcome

Timeframe: Daily during run-in and daily during treatment period of 6 weeks

Change in Percentage of nights with awakenings, average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.

Outcome measures

Outcome measures
Measure
With Spacer
n=55 Participants
Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer
n=52 Participants
Budesonide/formoterol pMDI 40/2.25 ug
Percentage of Nights With Awakenings Due to Asthma
-13.80 Percentage of nights
Standard Deviation 27.2
-8.20 Percentage of nights
Standard Deviation 23.8

SECONDARY outcome

Timeframe: Daily during run-in and daily during treatment period of 6 weeks

Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.

Outcome measures

Outcome measures
Measure
With Spacer
n=55 Participants
Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer
n=52 Participants
Budesonide/formoterol pMDI 40/2.25 ug
Use of Rescue Medication at Night
-0.21 Inhalations
Standard Deviation 0.50
-0.14 Inhalations
Standard Deviation 0.38

SECONDARY outcome

Timeframe: Daily during run-in and daily during treatment period of 6 weeks

Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.

Outcome measures

Outcome measures
Measure
With Spacer
n=55 Participants
Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer
n=52 Participants
Budesonide/formoterol pMDI 40/2.25 ug
Use of Rescue Medication at Day
-0.30 Inhalations
Standard Deviation 0.56
-0.19 Inhalations
Standard Deviation 0.41

Adverse Events

With Spacer

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Without Spacer

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

Gerard Lynch

AstraZeneca

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER