Trial Outcomes & Findings for A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma (NCT NCT00628758)
NCT ID: NCT00628758
Last Updated: 2012-08-14
Results Overview
Time to severe exacerbation among patients
COMPLETED
PHASE3
430 participants
26 weeks
2012-08-14
Participant Flow
FSI: LSI: LSO: Center type: Research and Training Host, Chest Medicine and Internal Medicine 23 Clinics. Number of enrolled subjects: 432, randomized: 430, completed patients: 344 ( Arm A:165, Arm B 179)
Participant milestones
| Measure |
Symbicort
Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
|
Conventional BP
Conventional Best Practice for Treatment of asthma
|
|---|---|---|
|
Overall Study
STARTED
|
209
|
221
|
|
Overall Study
COMPLETED
|
165
|
179
|
|
Overall Study
NOT COMPLETED
|
44
|
42
|
Reasons for withdrawal
| Measure |
Symbicort
Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
|
Conventional BP
Conventional Best Practice for Treatment of asthma
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Protocol Violation
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
25
|
31
|
|
Overall Study
Pregnancy
|
2
|
2
|
|
Overall Study
Investigator Moved
|
3
|
0
|
|
Overall Study
Treatment Failure
|
0
|
2
|
Baseline Characteristics
A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma
Baseline characteristics by cohort
| Measure |
Symbicort
n=209 Participants
Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
|
Conventional BP
n=221 Participants
Conventional Best Practice for Treatment of asthma
|
Total
n=430 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
44.28 years
STANDARD_DEVIATION 12.09 • n=5 Participants
|
45.17 years
STANDARD_DEVIATION 12.71 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
336 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeksTime to severe exacerbation among patients
Outcome measures
| Measure |
Symbicort
n=209 Participants
Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microgram (microg), 1 inh bid + as need)
|
Conventional Best Practice (BP)
n=221 Participants
Conventional Best Practice for Treatment of asthma
|
|---|---|---|
|
Time to First Severe Asthma Exacerbation
|
120.3 days
Standard Deviation 47.0
|
103.7 days
Standard Deviation 32.7
|
SECONDARY outcome
Timeframe: 26 weeksTotal number of severe asthma exacerbations per treatment group
Outcome measures
| Measure |
Symbicort
n=209 Participants
Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microgram (microg), 1 inh bid + as need)
|
Conventional Best Practice (BP)
n=221 Participants
Conventional Best Practice for Treatment of asthma
|
|---|---|---|
|
Number of Severe Asthma Exacerbations
|
10 Severe Exacerbations
|
10 Severe Exacerbations
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: ITT analysis was performed. Being in line with the analysis description population and due to the description of the variable. This patient-reported outcome variable could only be calculated for patients who have baseline and visit 4 AQLQ data. The AQLQ was not filled in by all enrolled patients.
Quality-of-Life assessment; grouped in four domains;activity limitation, symptoms, emotional function and exposure to environmental stimuli, using with a scale from 1 to 7 where 1 represents the greatest possible impairment and 7 represents the least impairment.
Outcome measures
| Measure |
Symbicort
n=146 Participants
Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microgram (microg), 1 inh bid + as need)
|
Conventional Best Practice (BP)
n=154 Participants
Conventional Best Practice for Treatment of asthma
|
|---|---|---|
|
Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score
|
3.98 Units on a scale
Standard Deviation 1.12
|
3.97 Units on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Daily recording during the treatment period of 26 weeksPopulation: ITT analysis was performed. Being in line with the analysis description population and due to description of the variable which was based on the patient's estimate, this variable could only be calculated of the patients who had recorded at least one estimate on their dairies they had been asked to return to the investigator at the study visits.
Mean use of as-needed medication per day during treatment period
Outcome measures
| Measure |
Symbicort
n=178 Participants
Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microgram (microg), 1 inh bid + as need)
|
Conventional Best Practice (BP)
n=193 Participants
Conventional Best Practice for Treatment of asthma
|
|---|---|---|
|
Mean Use of As-needed Medication Per Day During Treatment Period
|
0.91 inhalations per day
Standard Deviation 7.6
|
0.68 inhalations per day
Standard Deviation 5.7
|
Adverse Events
Symbicort
Conventional BP
Serious adverse events
| Measure |
Symbicort
n=209 participants at risk
Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
|
Conventional BP
n=221 participants at risk
Conventional Best Practice for Treatment of asthma
|
|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
0.48%
1/209
|
0.00%
0/221
|
|
Musculoskeletal and connective tissue disorders
Lower Limb Fracture
|
0.00%
0/209
|
0.45%
1/221
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/209
|
0.45%
1/221
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.48%
1/209
|
0.00%
0/221
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place