Trial Outcomes & Findings for Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia (NCT NCT00939341)

NCT ID: NCT00939341

Last Updated: 2012-01-16

Results Overview

Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 862 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2012-01-16

Participant Flow

A total of 1022 asthma patients were enrolled at 51 sites in 5 Asian countries: China (21 sites), India (12 sites), Indonesia (3 sites), Thailand (6 sites) and Taiwan (9 sites) during the period July 2009 to August 2010. Of the 1022 enrolled, 862 participants entered into a 12-week treatment with the investigational drug.

The study consisted of an initial screening visit followed by a 2-week run-in period before a 12-week treatment with investigational drug.

Participant milestones

Measure	Symbicort Turbuhaler 160/4.5 µg delivered dose
Overall Study STARTED	862
Overall Study COMPLETED	796
Overall Study NOT COMPLETED	66

Reasons for withdrawal

Measure	Symbicort Turbuhaler 160/4.5 µg delivered dose
Overall Study Adverse Event	15
Overall Study Pregnancy	1
Overall Study Lost to Follow-up	23
Overall Study Withdrawal by Subject	13
Overall Study Protocol Violation	6
Overall Study Incorrect enrolment	8

Baseline Characteristics

Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia

Baseline characteristics by cohort

Measure	Symbicort Turbuhaler n=862 Participants 160/4.5 µg delivered dose
Age Continuous All Participants	13.7 Years STANDARD_DEVIATION 44.7 • n=5 Participants
Sex: Female, Male Female	455 Participants n=5 Participants
Sex: Female, Male Male	407 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).

Outcome measures

Measure	Symbicort Turbuhaler n=841 Participants 160/4.5 µg delivered dose
Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level	-0.58 Units on a scale 95% Confidence Interval -0.64 • Interval -0.64 to -0.51

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.

Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).

Outcome measures

Measure	Symbicort Turbuhaler n=386 Participants 160/4.5 µg delivered dose
Change in ACQ(5) Score From Baseline at Country Level (China)	-0.58 Units on a scale 95% Confidence Interval -0.67 • Interval -0.67 to -0.49

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.

Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).

Outcome measures

Measure	Symbicort Turbuhaler n=159 Participants 160/4.5 µg delivered dose
Change in Overall ACQ(5) Score From Baseline at Country Level (India)	-0.74 Units on a scale 95% Confidence Interval -0.92 • Interval -0.92 to -0.57

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.

Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).

Outcome measures

Measure	Symbicort Turbuhaler n=61 Participants 160/4.5 µg delivered dose
Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)	-1.18 Units on a scale 95% Confidence Interval -1.40 • Interval -1.4 to -0.95

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.

Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).

Outcome measures

Measure	Symbicort Turbuhaler n=100 Participants 160/4.5 µg delivered dose
Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)	-0.22 Units on a scale 95% Confidence Interval -0.38 • Interval -0.38 to -0.06

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.

Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).

Outcome measures

Measure	Symbicort Turbuhaler n=128 Participants 160/4.5 µg delivered dose
Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)	-0.36 Units on a scale 95% Confidence Interval -0.48 • Interval -0.48 to -0.23

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)

Outcome measures

Measure	Symbicort Turbuhaler n=842 Participants 160/4.5 µg delivered dose
Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline	0.70 Units on a scale 95% Confidence Interval 0.64 • Interval 0.64 to 0.76

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).

Outcome measures

Measure	Symbicort Turbuhaler n=842 Participants 160/4.5 µg delivered dose
Change in AQLQ (S) Domain (Symptom) Scores From Baseline	0.77 Units on a scale 95% Confidence Interval 0.70 • Interval 0.7 to 0.84

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)

Outcome measures

Measure	Symbicort Turbuhaler n=842 Participants 160/4.5 µg delivered dose
Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline	0.59 Units on a scale 95% Confidence Interval 0.53 • Interval 0.53 to 0.65

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Participants' emotional functions were scored on a scale of decreasing impairment to emotional function from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) emotion function score were calculated as change from baseline (Week 0) to the treatment period (mean of the scores at Week 4, Week 8, Week 12)

Outcome measures

Measure	Symbicort Turbuhaler n=842 Participants 160/4.5 µg delivered dose
Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline	0.77 Units on a scale 95% Confidence Interval 0.70 • Interval 0.7 to 0.84

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Participants ' responses to environmental stimuli were scored on a scale of decreasing response to environmental stimuli from 1 to 7, in which 1 = maximum response. The change in overall mean AQLQ(S) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)

Outcome measures

Measure	Symbicort Turbuhaler n=842 Participants 160/4.5 µg delivered dose
Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline	0.67 Units on a scale 95% Confidence Interval 0.60 • Interval 0.6 to 0.74

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Change in the number of as-needed day-time inhalations of medication, defined as the difference in mean value of all available data obtained during treatment period and mean value in run-in period.

Outcome measures

Measure	Symbicort Turbuhaler n=841 Participants 160/4.5 µg delivered dose
Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Day-time Reliever Medication From run-in Period	-0.30 Number of inhalations 95% Confidence Interval -0.36 • Interval -0.36 to -0.23

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Change in the number of as-needed night-time inhalations of medication, calculated as difference in mean value of all available data obtained during treatment period and mean value in run-in period.

Outcome measures

Measure	Symbicort Turbuhaler n=852 Participants 160/4.5 µg delivered dose
Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Night-time Reliever Medication From run-in Period	-0.30 Number of inhalations 95% Confidence Interval -0.35 • Interval -0.35 to -0.24

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Total number of inhalations of Symbicort® 160µg/4.5µg per day during treatment period, defined as the sum of maintenance medication and as-needed medication during night and day time

Outcome measures

Measure	Symbicort Turbuhaler n=858 Participants 160/4.5 µg delivered dose
Study Medication Use (Maintenance and Reliever) in Diary Cards - Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period	2.51 Number of inhalations Standard Deviation 0.93

SECONDARY outcome

Timeframe: Baseline and 12 weeks

The mean percentage of days during treatment period participants used ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day

Outcome measures

Measure	Symbicort Turbuhaler n=858 Participants 160/4.5 µg delivered dose
Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 3 Inhalations of Symbicort® 160µg/4.5µg in a Day	28.25 Percentage of days Standard Deviation 33.03

SECONDARY outcome

Timeframe: Baseline and 12 weeks

The mean percentage of days during treatment period participants used ≥ 5 inhalations of Symbicort® 160µg/4.5µg in a day

Outcome measures

Measure	Symbicort Turbuhaler n=858 Participants 160/4.5 µg delivered dose
Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 5 Inhalations of of Symbicort® 160µg/4.5µg in a Day	6.21 Percentage of days Standard Deviation 16.17

SECONDARY outcome

Timeframe: Baseline and 12 weeks

The mean percentage of days during treatment period participants used ≥ 9 inhalations of Symbicort® 160µg/4.5µg in a day

Outcome measures

Measure	Symbicort Turbuhaler n=858 Participants 160/4.5 µg delivered dose
Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 9 Inhalations of Symbicort® 160µg/4.5µg in a Day	0.19 Percentage of days Standard Deviation 1.92

Adverse Events

Symbicort Turbuhaler

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Symbicort Turbuhaler n=862 participants at risk 160/4.5 µg delivered dose
Respiratory, thoracic and mediastinal disorders Asthma	0.23% 2/862
Nervous system disorders Headache	0.12% 1/862
Nervous system disorders Cerebral Infarction	0.12% 1/862
Cardiac disorders Myocardial Infarction	0.12% 1/862
Respiratory, thoracic and mediastinal disorders Nasal Polyps	0.12% 1/862
Surgical and medical procedures Post procedural haemorrhage	0.12% 1/862
Infections and infestations Pneumonia	0.12% 1/862
Gastrointestinal disorders Inguinal hernia	0.12% 1/862
Renal and urinary disorders Renal Cysts	0.12% 1/862
Infections and infestations Appendicitis	0.12% 1/862
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.12% 1/862
Gastrointestinal disorders Ileus	0.12% 1/862
Reproductive system and breast disorders Breast Cancer	0.12% 1/862
Vascular disorders Atrioventricular block complete	0.12% 1/862

Other adverse events

Adverse event data not reported

Additional Information

Gerard Lynch

AstraZeneca

Phone: +44 1625 518062

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

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