Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of an initial screening visit followed by a 2-week run-in period before a 12-week treatment with investigational drug.

Reporting Groups

	Description
Symbicort Turbuhaler	160/4.5 µg delivered dose

Participant Flow:   Overall Study

	Symbicort Turbuhaler
STARTED	862 [1]
COMPLETED	796 [2]
NOT COMPLETED	66
Adverse Event	15
Pregnancy	1
Lost to Follow-up	23
Withdrawal by Subject	13
Protocol Violation	6
Incorrect enrolment	8

Reporting Groups

	Description
Symbicort Turbuhaler	160/4.5 µg delivered dose

Baseline Measures

	Symbicort Turbuhaler
Number of Participants   [units: participants]	862
Age   [units: Years] Mean ± Standard Deviation
All Participants	13.7  ± 44.7
Gender   [units: Participants]
Female	455
Male	407

1.  Primary:

Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:

Change in ACQ(5) Score From Baseline at Country Level (China)   [ Time Frame: Baseline and 12 weeks ]

3.  Secondary:

Change in Overall ACQ(5) Score From Baseline at Country Level (India)   [ Time Frame: Baseline and 12 weeks ]

4.  Secondary:

Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)   [ Time Frame: Baseline and 12 weeks ]

5.  Secondary:

Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)   [ Time Frame: Baseline and 12 weeks ]

6.  Secondary:

Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)   [ Time Frame: Baseline and 12 weeks ]

7.  Secondary:

Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline   [ Time Frame: Baseline and 12 weeks ]

8.  Secondary:

Change in AQLQ (S) Domain (Symptom) Scores From Baseline   [ Time Frame: Baseline and 12 weeks ]

9.  Secondary:

Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline   [ Time Frame: Baseline and 12 weeks ]

10.  Secondary:

Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline   [ Time Frame: Baseline and 12 weeks ]

11.  Secondary:

Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline   [ Time Frame: Baseline and 12 weeks ]

12.  Secondary:

Study Medication Use (Maintenance and Reliever) in Diary Cards – Change in As-needed Day-time Reliever Medication From run-in Period   [ Time Frame: Baseline and 12 weeks ]

13.  Secondary:

Study Medication Use (Maintenance and Reliever) in Diary Cards – Change in As-needed Night-time Reliever Medication From run-in Period   [ Time Frame: Baseline and 12 weeks ]

14.  Secondary:

Study Medication Use (Maintenance and Reliever) in Diary Cards – Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period   [ Time Frame: Baseline and 12 weeks ]

15.  Secondary:

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   [ Time Frame: Baseline and 12 weeks ]

16.  Secondary:

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   [ Time Frame: Baseline and 12 weeks ]

17.  Secondary:

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   [ Time Frame: Baseline and 12 weeks ]