Asthma Control Test Guided Treatment in Chinese Subjects

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02868281
• Collaborator: MacroStat (Other)
• Enrollment: 530
• Locations: 6
• Arms: 2
• Actual Duration (Months): 35.4
• Patients Per Site: 88.3
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

This study is aimed to evaluate the effectiveness of Asthma Control Test (ACT) guided treatment compared with usual care in asthma subjects in China. It is designed to assist Chinese subjects and physicians improving adherence to the guidelines through the inclusion of the ACT in the patient's asthma management plan. This is a prospective, multicentre, cluster-randomized, open-label 24-week study. In this cluster-randomization design, each study center, considered as a cluster, will be randomized to either ACT guided treatment group or control group (usual care group). For the subjects who are recruited in the ACT centers, they will be treated based on the ACT score. If ACT score are equal to (=) 25 for more than equal to (>=) 3 months then the treatment will stepped-down; if ACT score >=20, less than (<) 25 or ACT=25 for <3 months then there will be no change and if ACT score less than (<=) 19 then the treatment will stepped-up. For subjects who are recruited in the control centers, they will be treated based on doctor's subjective judgment. Assignment to a treatment will not occur, as no treatment intervention is provided for this study. A total of 528 asthma subjects are planned in the study. The randomization will be stratified according to the Tier of the hospitals (Tier 3 verses Tier 2).

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: ACT guided Routine Treatment; Drug: Routine Treatment	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 530 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effectiveness of Asthma Control Test Guided Treatment Compared With Usual Care in China Adult Asthma Patients
• Actual Study Start Date: Aug 26, 2016
• Actual Primary Completion Date: Aug 9, 2019
• Actual Study Completion Date: Aug 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects recruited at ACT centers For the subjects who will be recruited in the ACT centers, they will be treated based on the ACT score. If ACT score are = 25 for >=3 months then step-down the treatment; if ACT score >=20, <25 or ACT=25 for <3 months then there will be no change and if ACT score less than (<=) 19 then step-up the treatment.	Drug: ACT guided Routine Treatment; The ACT is a validated, short, easy to use, and self-administered instrument used to assess asthma control. Subjects in this group received routine treatment as per ACT score.
Active Comparator: Subjects recruited in the control centers For subjects who will be recruited in the control centers, they will be treated based on doctor's subjective judgment.	Drug: Routine Treatment; Subjects in the controlled treatment group will receive usual care of asthma. This treatment was monitored and adjusted as usual by the patient's general practitioner.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Had an ACT Total Score >=20 or an Improvement of More Than 3 Points in ACT During the 24-week Treatment Period [Up to Week 24]

   ACT is a self-administered questionnaire comprising five items that were assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of >=20 denoting 'well-controlled asthma', a score of 16-19 denoting 'not well-controlled asthma', and a score of <=15 denoting 'very poorly controlled asthma'. The total score was calculated as the sum of the scores from all 5 questions. Higher scores indicates improved asthma control. The recall period of the questionnaire was four weeks.

Secondary Outcome Measures

1. Mean Daytime Symptom Score Over the 24-week Treatment Period [Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24]

   Participants recorded daytime asthma symptom scores in the daily record card (DRC). Any asthma-related symptoms, such as wheeze, shortness of breath, cough or chest tightness experienced during the previous 12 hours were rated as: 0= no symptoms during the day, 1= symptoms for one short period during the day, 2= symptoms for two or more short periods during the day, 3= symptoms for most of the day which did not affect daily activities, 4= symptoms for most of the day which did affect normal daily activities, 5= symptoms so severe that participant could not go to work or perform normal daily activities. Daytime symptom score was calculated by taking average of scores for all questions. The mean daytime asthma symptom score was calculated for each participant during the 4-weekly interval (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. Score ranged from 0-5, higher scores indicates severe symptoms.

2. Mean Night-time Symptom Score Over the 24-week Treatment Period [Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24]

   Participants recorded night-time asthma symptom scores in the DRC. Any asthma-related symptoms, such as wheeze, shortness of breath, cough or chest tightness experienced during the previous 12 hours were rated as: 0= no symptoms during the night, 1= symptoms causing to wake once or wake early, 2= symptoms causing to wake twice or more (including waking early), 3= symptoms causing to be awake for most of the night, 4= symptoms so severe that participant did not sleep at all. Night-time symptom score was calculated by taking average of scores for all questions. The mean nighttime asthma symptom score was calculated for each participant during the 4 weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. Score ranged from 0-5, higher scores indicates severe symptoms.

3. Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 24 [Baseline (Day 1) and at Week 24]

   FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured by spirometry. Baseline was defined as value at Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

4. Mean Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) Over the 24-week Treatment Period [Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24]

   PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Participants were provided with a Mini-Wright Peak Flow Meter and were taught how to measure and record their PEF. Participants recorded on DRC the best of three PEF measurements, using a Mini-Wright peak flow meter in the morning (7:00 to 10:00 AM) before taking any asthma drug. Mean AM PEF was calculated for each participant during the 4-weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks.

5. Mean Evening (Post Meridiem [PM]) PEF Over the 24-week Treatment Period [Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24]

   PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Participants were provided with a Mini-Wright Peak Flow Meter and were taught how to measure and record their PEF. Participants recorded on DRC the best of three PEF measurements, using a Mini-Wright peak flow meter in the evening (6:00 to 9:00 PM) before taking any asthma drug. Mean PM PEF was calculated for each participant during the 4-weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks.

6. Mean Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Total Score at Week 24 [Baseline (Day 1) and at Week 24]

   The AQLQ(S) contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). Participant's response to each question was rated on a seven-point scale (1 to 7) where a value of 1 indicates "total impairment" and a value of 7 indicates "no impairment". The total AQLQ(S) score is calculated as the mean of all 32 items in the questionnaire. Hence, the total AQLQ(S) score ranged from 1 to 7 with higher scores indicating a higher quality of life. A change in score of greater than 0.5 can be considered clinically important. Baseline was defined as value at Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

7. Time to First ACT Score >=20 or Improvement of More Than 3 Points in ACT Over the 24-week Treatment Period [Up to Week 24]

   ACT is a self-administered questionnaire comprising five items that were assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of >=20 denoting 'well-controlled asthma', a score of 16-19 denoting 'not well-controlled asthma', and a score of <=15 denoting 'very poorly controlled asthma'. Higher scores indicates improved asthma control. The recall period of the questionnaire was four weeks. Median and inter-quartile range (first and third quartiles) are presented for time to first ACT score >=20 or improvement of more than 3 points in ACT over the 24-week treatment period.

Other Outcome Measures

1. Annualized Rate of Moderate to Severe Asthma Exacerbation During 24-week Treatment Period [Up to Week 24]

   Exacerbations were assessed by the physician at each scheduled visit by reviewing the DRC, as well as specific questioning on adverse events. A moderate asthma exacerbation was defined as a deterioration in asthma requiring treatment with an oral corticosteroid. Individual courses of oral corticosteroids were classified as separate exacerbations only if they were administered more than 1 week apart. Any course started within one week of finishing the previous course was considered part of the previous exacerbation. A severe asthma exacerbation was defined as a deterioration in asthma which requires hospital admission. Annualized Rate of moderate to severe asthma exacerbation during 24-week treatment period is presented.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Inclusion criteria for study centre (clusters):

• General practice

• Located in Shanghai

• Providing asthma care

Inclusion Criteria for subject at Visit 0

• Age: 18 to 70 inclusive

• Gender: Male or Female

• Documented clinical history of asthma for at least 6 months prior to Visit 0

• At Visit 0, a demonstrable reversible increase in FEV1 of at least 12 percent (%) (and

=200 milliliter [mL]), 15 minutes after inhaling a short-acting bronchodilator or; at any time in the last 2 years documentary evidence of a reversible increase in FEV1 of at least 12% (and >=200 mL) 15 minutes after inhaling a short-acting bronchodilator; or demonstrable reversible increase in morning PEF of at least 15% (and >=200 mL) either spontaneously or after inhalation of a short-acting bronchodilator

• History of using inhaled corticosteroids alone or combined with an inhaled long-acting beta two agonist (LABA) treatment within 1 year prior to Visit 0

• Subjects must have an ACT score <20 at Visit 0

• Subject must have been able to read, comprehend, and record information in Chinese

• A signed and dated written informed consent must be obtained from the subject prior to study participation

Exclusion Criteria:

• History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months before Visit 0

• Subjects having severe and unstable asthma, with ACT score <12 at Visit 0, history of repeated severe exacerbations (3 per year) and/or a severe exacerbation in the previous 6 weeks before Visit 0.

• A current evidence of clinically significant uncontrolled medical condition or disease (e.g., psychological disorders, mental deficiency, severe hepatic and renal dysfunction, malignancy)

• Current smoker or ex-smoker with a more than 10 pack-year history of smoking

• Current clinically significant respiratory diseases other than asthma, (e.g., lung cancer, lung fibrosis, sarcoidosis, tuberculosis, chronic obstructive pulmonary disease)

• History of alcohol or medication abuse

• History of upper or lower respiratory tract infection within 4 weeks prior to Visit 0

• Enrolled in an asthma clinic or outpatient service in the past 12 months that provides comprehensive asthma management

• Subjects with a history of adverse reaction including immediate or delayed hypersensitivity to any intranasal, inhaled, or systemic corticosteroid and LABA therapy and to components of the inhalation powder (e.g., lactose) at Visit 0. In addition, subjects with a history of severe milk protein allergy that, in the opinion of the Investigator, contraindicates the subject's participation will also be excluded

• Females who are currently pregnant and lactating

• Subjects who have received any of the following medications in the 6 weeks preceding visit 0: oral/parenteral corticosteroids, oral beta two-agonists or slow-release bronchodilators, sodium cromoglycate or nedocromil sodium, ketotifen, anticholinergics, and anti-Immunoglobulin-E treatment

• Subjects who comply poorly with asthma treatment in the opinion of the investigator/inability or unwillingness to take asthma medication (non-compliance), follow directions or unable to complete a written paper daily record card and self-rating questionnaires

• Concurrently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational medication or device, or has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)

• Subjects with contraindications to any asthma medications they will be taking during the study period, or whom should be excluded on account of the special warnings and precautions within the label of the asthma medication they are to be treated with during the study period

• Affiliation with Investigator Site: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the afore mentioned that is involved in this study

• Subjects who plan to move away from the geographical area where the study is being conducted during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Shanghai		China	200032
2	GSK Investigational Site	Shanghai		China	200052
3	GSK Investigational Site	Shanghai		China	200135
4	GSK Investigational Site	Shanghai		China	201299
5	GSK Investigational Site	Shanghai		China	201700
6	GSK Investigational Site	Shanghai		China

Sponsors and Collaborators

• GlaxoSmithKline
• MacroStat

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Jun 27, 2016
• Statistical Analysis Plan - Sep 11, 2019

More Information

Publications

• Ye L, Gao X, Tu C, Du C, Gu W, Hang J, Zhao L, Jie Z, Li H, Lu Y, Wang J, Jin X, Hu X, Wu S, Jin M. Comparative analysis of effectiveness of asthma control test-guided treatment versus usual care in patients with asthma from China. Respir Med. 2021 Jun;182:106382. doi: 10.1016/j.rmed.2021.106382. Epub 2021 Mar 30.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02868281
• Other Study ID Numbers: 201097
• First Posted: Aug 16, 2016
• Last Update Posted: Jul 8, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Cluster Randomization; Peak Expiratory Flow; Forced Expiratory Volume; Standardized Asthma Quality of Life Questionnaire; Asthma Control Test
• Additional relevant MeSH terms: Asthma

Study Results

Participant Flow

Recruitment Details	Participants were enrolled from 12 centers in China.
Pre-assignment Detail	Total 583 participants were screened and 530 participants were enrolled into the study (53 participants were screen failures).

Arm/Group Title	ACT Guided Treatment Group	Usual Care Group
Arm/Group Description	Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.	Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
Period Title: Overall Study
STARTED	252	278
COMPLETED	209	234
NOT COMPLETED	43	44

Baseline Characteristics

Arm/Group Title	ACT Guided Treatment Group	Usual Care Group	Total
Arm/Group Description	Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.	Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.	Total of all reporting groups
Overall Participants	252	278	530
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	47.9 (12.74)	48.1 (13.39)	48.0 (13.07)
Sex: Female, Male (Count of Participants)
Female	122 48.4%	141 50.7%	263 49.6%
Male	130 51.6%	137 49.3%	267 50.4%
Race/Ethnicity, Customized (Count of Participants)
Asian-East Asian Heritage	252 100%	278 100%	530 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Had an ACT Total Score >=20 or an Improvement of More Than 3 Points in ACT During the 24-week Treatment Period
Description	ACT is a self-administered questionnaire comprising five items that were assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of >=20 denoting 'well-controlled asthma', a score of 16-19 denoting 'not well-controlled asthma', and a score of <=15 denoting 'very poorly controlled asthma'. The total score was calculated as the sum of the scores from all 5 questions. Higher scores indicates improved asthma control. The recall period of the questionnaire was four weeks.
Time Frame	Up to Week 24

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) Population consisted of all participants who signed informed consent form, were randomized and who had at least one post-Baseline assessment. Only those participants with data available at the specified data point were analyzed.

Arm/Group Title	ACT Guided Treatment Group	Usual Care Group
Arm/Group Description	Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.	Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
Measure Participants	240	262
Number [Percentage of participants]	99.2 39.4%	94.3 33.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments
	Method	Mixed effect logistic regression
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	7.87
	Confidence Interval	(2-Sided) 95%; 1.29 to 48.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	The model included treatment, Baseline ACT total score, Baseline ACT total score squared, center, type of Baseline controller, gender and age, with the center as a random factor.

2. Secondary Outcome

Title	Mean Daytime Symptom Score Over the 24-week Treatment Period
Description	Participants recorded daytime asthma symptom scores in the daily record card (DRC). Any asthma-related symptoms, such as wheeze, shortness of breath, cough or chest tightness experienced during the previous 12 hours were rated as: 0= no symptoms during the day, 1= symptoms for one short period during the day, 2= symptoms for two or more short periods during the day, 3= symptoms for most of the day which did not affect daily activities, 4= symptoms for most of the day which did affect normal daily activities, 5= symptoms so severe that participant could not go to work or perform normal daily activities. Daytime symptom score was calculated by taking average of scores for all questions. The mean daytime asthma symptom score was calculated for each participant during the 4-weekly interval (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. Score ranged from 0-5, higher scores indicates severe symptoms.
Time Frame	Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified data point were analyzed (represented by n=x in the category titles).

Arm/Group Title	ACT Guided Treatment Group	Usual Care Group
Arm/Group Description	Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.	Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
Measure Participants	236	259
Weeks 1-4, n=236, 259	0.3 (0.05)	0.4 (0.05)
Weeks 5-8, n=227, 249	0.2 (0.05)	0.3 (0.05)
Weeks 9-12, n=217, 240	0.2 (0.05)	0.2 (0.05)
Weeks 13-16, n=210, 238	0.1 (0.05)	0.2 (0.05)
Weeks 17-20, n=207, 233	0.1 (0.05)	0.2 (0.05)
Weeks 21-24, n=205, 227	0.1 (0.05)	0.2 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.222
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.156
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.245
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.057
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.151
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.114
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

3. Secondary Outcome

Title	Mean Night-time Symptom Score Over the 24-week Treatment Period
Description	Participants recorded night-time asthma symptom scores in the DRC. Any asthma-related symptoms, such as wheeze, shortness of breath, cough or chest tightness experienced during the previous 12 hours were rated as: 0= no symptoms during the night, 1= symptoms causing to wake once or wake early, 2= symptoms causing to wake twice or more (including waking early), 3= symptoms causing to be awake for most of the night, 4= symptoms so severe that participant did not sleep at all. Night-time symptom score was calculated by taking average of scores for all questions. The mean nighttime asthma symptom score was calculated for each participant during the 4 weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. Score ranged from 0-5, higher scores indicates severe symptoms.
Time Frame	Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified data point were analyzed (represented by n=x in the category titles).

Arm/Group Title	ACT Guided Treatment Group	Usual Care Group
Arm/Group Description	Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.	Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
Measure Participants	236	258
Weeks 1-4, n=236, 258	0.4 (0.07)	0.5 (0.06)
Weeks 5-8, n=226, 249	0.3 (0.06)	0.3 (0.06)
Weeks 9-12, n=217, 240	0.2 (0.06)	0.3 (0.06)
Weeks 13-16, n=209, 238	0.2 (0.06)	0.3 (0.06)
Weeks 17-20, n=207, 233	0.2 (0.06)	0.2 (0.06)
Weeks 21-24, n=205, 227	0.2 (0.06)	0.2 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.487
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 95%; -0.18 to 0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.546
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 95%; -0.16 to 0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.314
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95%; -0.17 to 0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.197
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 95%; -0.19 to 0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.282
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95%; -0.17 to 0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.543
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95%; -0.15 to 0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

4. Secondary Outcome

Title	Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 24
Description	FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured by spirometry. Baseline was defined as value at Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame	Baseline (Day 1) and at Week 24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified data point were analyzed.

Arm/Group Title	ACT Guided Treatment Group	Usual Care Group
Arm/Group Description	Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.	Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
Measure Participants	208	227
Least Squares Mean (Standard Error) [Liters]	0.159 (0.0573)	0.098 (0.0559)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.273
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	0.060
	Confidence Interval	(2-Sided) 95%; -0.059 to 0.180
	Parameter Dispersion	Type: Value:
	Estimation Comments	The model included covariates of treatment, center, Baseline FEV1, type of Baseline controller, gender and age, with the center as a random factor.

5. Secondary Outcome

Title	Mean Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) Over the 24-week Treatment Period
Description	PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Participants were provided with a Mini-Wright Peak Flow Meter and were taught how to measure and record their PEF. Participants recorded on DRC the best of three PEF measurements, using a Mini-Wright peak flow meter in the morning (7:00 to 10:00 AM) before taking any asthma drug. Mean AM PEF was calculated for each participant during the 4-weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks.
Time Frame	Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified data point were analyzed (represented by n=x in the category titles).

Arm/Group Title	ACT Guided Treatment Group	Usual Care Group
Arm/Group Description	Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.	Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
Measure Participants	239	261
Weeks 1-4, n=239, 261	340.4 (13.37)	352.4 (13.03)
Weeks 5-8, n=228, 251	355.5 (13.39)	362.7 (13.05)
Weeks 9-12, n=220, 241	362.2 (13.42)	366.9 (13.08)
Weeks 13-16, n=211, 239	364.6 (13.40)	367.9 (13.06)
Weeks 17-20, n=207, 235	366.0 (13.38)	371.0 (13.04)
Weeks 21-24, n=206, 229	367.0 (13.43)	371.0 (13.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.367
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-12.0
	Confidence Interval	(2-Sided) 95%; -40.3 to 16.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.587
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-7.2
	Confidence Interval	(2-Sided) 95%; -35.5 to 21.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.721
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-4.7
	Confidence Interval	(2-Sided) 95%; -33.1 to 23.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.801
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-3.3
	Confidence Interval	(2-Sided) 95%; -31.7 to 25.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.704
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -33.3 to 23.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.762
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-4.0
	Confidence Interval	(2-Sided) 95%; -32.4 to 24.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

6. Secondary Outcome

Title	Mean Evening (Post Meridiem [PM]) PEF Over the 24-week Treatment Period
Description	PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Participants were provided with a Mini-Wright Peak Flow Meter and were taught how to measure and record their PEF. Participants recorded on DRC the best of three PEF measurements, using a Mini-Wright peak flow meter in the evening (6:00 to 9:00 PM) before taking any asthma drug. Mean PM PEF was calculated for each participant during the 4-weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks.
Time Frame	Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified data point were analyzed (represented by n=x in the category titles).

Arm/Group Title	ACT Guided Treatment Group	Usual Care Group
Arm/Group Description	Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.	Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
Measure Participants	239	261
Weeks 1-4, n=239, 261	342.2 (13.55)	354.9 (13.22)
Weeks 5-8, n=228, 251	356.2 (13.60)	364.6 (13.27)
Weeks 9-12, n=220, 241	362.7 (13.63)	367.7 (13.29)
Weeks 13-16, n=211, 239	365.8 (13.61)	368.9 (13.27)
Weeks 17-20, n=207, 235	366.9 (13.60)	370.9 (13.26)
Weeks 21-24, n=206, 229	368.1 (13.67)	372.0 (13.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.354
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-12.8
	Confidence Interval	(2-Sided) 95%; -42.1 to 16.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.538
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-8.4
	Confidence Interval	(2-Sided) 95%; -37.8 to 21.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.716
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -34.4 to 24.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.822
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-3.1
	Confidence Interval	(2-Sided) 95%; -32.5 to 26.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.767
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-4.0
	Confidence Interval	(2-Sided) 95%; -33.4 to 25.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.779
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	-3.8
	Confidence Interval	(2-Sided) 95%; -33.4 to 25.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.

7. Secondary Outcome

Title	Mean Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Total Score at Week 24
Description	The AQLQ(S) contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). Participant's response to each question was rated on a seven-point scale (1 to 7) where a value of 1 indicates "total impairment" and a value of 7 indicates "no impairment". The total AQLQ(S) score is calculated as the mean of all 32 items in the questionnaire. Hence, the total AQLQ(S) score ranged from 1 to 7 with higher scores indicating a higher quality of life. A change in score of greater than 0.5 can be considered clinically important. Baseline was defined as value at Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time Frame	Baseline (Day 1) and at Week 24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified data point were analyzed.

Arm/Group Title	ACT Guided Treatment Group	Usual Care Group
Arm/Group Description	Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.	Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
Measure Participants	202	231
Least Squares Mean (Standard Error) [Scores on a scale]	1.5 (0.13)	1.2 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.059
	Comments
	Method	Mixed Model Repeat Measures
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Mean
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -0.0 to 0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	The model included covariates of treatment, center, Baseline AQLQ(S) score, type of Baseline controller, gender and age, with the center as a random factor.

8. Secondary Outcome

Title	Time to First ACT Score >=20 or Improvement of More Than 3 Points in ACT Over the 24-week Treatment Period
Description	ACT is a self-administered questionnaire comprising five items that were assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of >=20 denoting 'well-controlled asthma', a score of 16-19 denoting 'not well-controlled asthma', and a score of <=15 denoting 'very poorly controlled asthma'. Higher scores indicates improved asthma control. The recall period of the questionnaire was four weeks. Median and inter-quartile range (first and third quartiles) are presented for time to first ACT score >=20 or improvement of more than 3 points in ACT over the 24-week treatment period.
Time Frame	Up to Week 24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified data point were analyzed.

Arm/Group Title	ACT Guided Treatment Group	Usual Care Group
Arm/Group Description	Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.	Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
Measure Participants	229	224
Median (Inter-Quartile Range) [Days]	33.0	55.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.010
	Comments
	Method	Cox proportional hazards model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.843
	Confidence Interval	(2-Sided) 95%; 1.160 to 2.926
	Parameter Dispersion	Type: Value:
	Estimation Comments	The model included treatment, Baseline ACT total score, center, type of Baseline controller, gender and age as covariates.

9. Other Pre-specified Outcome

Title	Annualized Rate of Moderate to Severe Asthma Exacerbation During 24-week Treatment Period
Description	Exacerbations were assessed by the physician at each scheduled visit by reviewing the DRC, as well as specific questioning on adverse events. A moderate asthma exacerbation was defined as a deterioration in asthma requiring treatment with an oral corticosteroid. Individual courses of oral corticosteroids were classified as separate exacerbations only if they were administered more than 1 week apart. Any course started within one week of finishing the previous course was considered part of the previous exacerbation. A severe asthma exacerbation was defined as a deterioration in asthma which requires hospital admission. Annualized Rate of moderate to severe asthma exacerbation during 24-week treatment period is presented.
Time Frame	Up to Week 24

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants with data available at the specified data point were analyzed.

Arm/Group Title	ACT Guided Treatment Group	Usual Care Group
Arm/Group Description	Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.	Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
Measure Participants	241	263
Mean (95% Confidence Interval) [Exacerbations per year]	0.10	0.09

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACT Guided Treatment Group, Usual Care Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.897
	Comments
	Method	Generalised linear model
	Comments
Method of Estimation	Estimation Parameter	Rate Ratio
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95%; 0.32 to 3.73
	Parameter Dispersion	Type: Value:
	Estimation Comments	The model included treatment, Baseline ACT total score, type of Baseline controller, gender and age as covariates.

Adverse Events

Time Frame	Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Adverse Event Reporting Description	Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
Arm/Group Title	ACT Guided Treatment Group		Usual Care Group
Arm/Group Description	Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for >=3 months, then step-down treatment. If ACT score >=20 or <25 or ACT =25 for <3 months, then no change in treatment. If ACT score <=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.		Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
All Cause Mortality
	ACT Guided Treatment Group		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/252 (0.4%)		0/278 (0%)
Serious Adverse Events
	ACT Guided Treatment Group		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/252 (3.6%)		14/278 (5%)
Cardiac disorders
Arrhythmia	1/252 (0.4%)		1/278 (0.4%)
Ventricular extrasystoles	1/252 (0.4%)		0/278 (0%)
Angina unstable	0/252 (0%)		1/278 (0.4%)
Coronary artery disease	0/252 (0%)		2/278 (0.7%)
Congenital, familial and genetic disorders
Branchial cleft sinus	0/252 (0%)		1/278 (0.4%)
Eye disorders
Macular oedema	0/252 (0%)		1/278 (0.4%)
Gastrointestinal disorders
Large intestine polyp	1/252 (0.4%)		0/278 (0%)
Upper gastrointestinal haemorrhage	1/252 (0.4%)		0/278 (0%)
Haematochezia	0/252 (0%)		1/278 (0.4%)
Haemorrhoids	0/252 (0%)		1/278 (0.4%)
Hypertrophic anal papilla	0/252 (0%)		1/278 (0.4%)
General disorders
Chest pain	0/252 (0%)		1/278 (0.4%)
Infections and infestations
Chronic sinusitis	1/252 (0.4%)		0/278 (0%)
Otitis media chronic	1/252 (0.4%)		0/278 (0%)
Salpingitis	1/252 (0.4%)		0/278 (0%)
Bronchitis	0/252 (0%)		1/278 (0.4%)
Injury, poisoning and procedural complications
Meniscus injury	1/252 (0.4%)		0/278 (0%)
Humerus fracture	0/252 (0%)		1/278 (0.4%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/252 (0.4%)		0/278 (0%)
Fistula	0/252 (0%)		1/278 (0.4%)
Intervertebral disc protrusion	0/252 (0%)		2/278 (0.7%)
Lumbar spinal stenosis	0/252 (0%)		1/278 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma	2/252 (0.8%)		0/278 (0%)
Gastric cancer	0/252 (0%)		1/278 (0.4%)
Melanocytic naevus	0/252 (0%)		1/278 (0.4%)
Nervous system disorders
Epilepsy	1/252 (0.4%)		0/278 (0%)
Renal and urinary disorders
Nephrolithiasis	0/252 (0%)		1/278 (0.4%)
Ureterolithiasis	0/252 (0%)		1/278 (0.4%)
Reproductive system and breast disorders
Pelvic adhesions	1/252 (0.4%)		0/278 (0%)
Uterine polyp	1/252 (0.4%)		0/278 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	2/252 (0.8%)		2/278 (0.7%)
Nasal polyps	1/252 (0.4%)		0/278 (0%)
Vascular disorders
Varicose vein	1/252 (0.4%)		0/278 (0%)
Subclavian artery occlusion	0/252 (0%)		1/278 (0.4%)
Other (Not Including Serious) Adverse Events
	ACT Guided Treatment Group		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	82/252 (32.5%)		123/278 (44.2%)
Blood and lymphatic system disorders
Lymphadenitis	1/252 (0.4%)		2/278 (0.7%)
Cardiac disorders
Palpitations	1/252 (0.4%)		2/278 (0.7%)
Ventricular extrasystoles	1/252 (0.4%)		0/278 (0%)
Angina pectoris	0/252 (0%)		1/278 (0.4%)
Ear and labyrinth disorders
Deafness neurosensory	1/252 (0.4%)		0/278 (0%)
Tinnitus	0/252 (0%)		1/278 (0.4%)
Vertigo	0/252 (0%)		1/278 (0.4%)
Endocrine disorders
Adrenal mass	1/252 (0.4%)		0/278 (0%)
Thyroid mass	1/252 (0.4%)		0/278 (0%)
Hyperthyroidism	0/252 (0%)		1/278 (0.4%)
Eye disorders
Ocular hyperaemia	1/252 (0.4%)		0/278 (0%)
Scleritis	1/252 (0.4%)		0/278 (0%)
Conjunctival haemorrhage	0/252 (0%)		1/278 (0.4%)
Vitreous opacities	0/252 (0%)		1/278 (0.4%)
Gastrointestinal disorders
Abdominal pain	3/252 (1.2%)		0/278 (0%)
Diarrhoea	3/252 (1.2%)		0/278 (0%)
Dyspepsia	2/252 (0.8%)		0/278 (0%)
Gastritis	2/252 (0.8%)		0/278 (0%)
Gastrooesophageal reflux disease	2/252 (0.8%)		0/278 (0%)
Chronic gastritis	1/252 (0.4%)		0/278 (0%)
Dysbacteriosis	1/252 (0.4%)		0/278 (0%)
Enteritis	1/252 (0.4%)		1/278 (0.4%)
Gastrointestinal hypomotility	1/252 (0.4%)		0/278 (0%)
Gingival pain	1/252 (0.4%)		0/278 (0%)
Gingival swelling	1/252 (0.4%)		0/278 (0%)
Haemorrhoids	1/252 (0.4%)		0/278 (0%)
Toothache	1/252 (0.4%)		2/278 (0.7%)
Vomiting	1/252 (0.4%)		0/278 (0%)
Abdominal discomfort	0/252 (0%)		1/278 (0.4%)
Breath odour	0/252 (0%)		1/278 (0.4%)
Flatulence	0/252 (0%)		2/278 (0.7%)
Gastrointestinal disorder	0/252 (0%)		1/278 (0.4%)
Mouth ulceration	0/252 (0%)		1/278 (0.4%)
Nausea	0/252 (0%)		1/278 (0.4%)
Stomatitis	0/252 (0%)		1/278 (0.4%)
Tooth impacted	0/252 (0%)		1/278 (0.4%)
General disorders
Pyrexia	5/252 (2%)		4/278 (1.4%)
Chest discomfort	4/252 (1.6%)		1/278 (0.4%)
Chest pain	2/252 (0.8%)		2/278 (0.7%)
Discomfort	0/252 (0%)		1/278 (0.4%)
Fatigue	0/252 (0%)		1/278 (0.4%)
Hepatobiliary disorders
Hepatic steatosis	1/252 (0.4%)		1/278 (0.4%)
Immune system disorders
Hypersensitivity	1/252 (0.4%)		3/278 (1.1%)
Infections and infestations
Upper respiratory tract infection	18/252 (7.1%)		47/278 (16.9%)
Rhinitis	6/252 (2.4%)		3/278 (1.1%)
Nasopharyngitis	4/252 (1.6%)		4/278 (1.4%)
Bronchitis	3/252 (1.2%)		16/278 (5.8%)
Conjunctivitis	3/252 (1.2%)		3/278 (1.1%)
Respiratory tract infection	3/252 (1.2%)		6/278 (2.2%)
Urinary tract infection	3/252 (1.2%)		0/278 (0%)
Gastroenteritis	2/252 (0.8%)		0/278 (0%)
Otitis media	2/252 (0.8%)		1/278 (0.4%)
Pelvic inflammatory disease	2/252 (0.8%)		0/278 (0%)
Vaginal infection	2/252 (0.8%)		0/278 (0%)
Herpes zoster	1/252 (0.4%)		1/278 (0.4%)
Pharyngitis	1/252 (0.4%)		1/278 (0.4%)
Pulpitis dental	1/252 (0.4%)		1/278 (0.4%)
Sinusitis	1/252 (0.4%)		0/278 (0%)
Tinea cruris	1/252 (0.4%)		0/278 (0%)
Tinea pedis	1/252 (0.4%)		0/278 (0%)
Conjunctivitis viral	0/252 (0%)		1/278 (0.4%)
Lung infection	0/252 (0%)		1/278 (0.4%)
Otitis externa	0/252 (0%)		1/278 (0.4%)
Periodontitis	0/252 (0%)		2/278 (0.7%)
Tonsillitis	0/252 (0%)		1/278 (0.4%)
Tooth abscess	0/252 (0%)		1/278 (0.4%)
Urethritis	0/252 (0%)		1/278 (0.4%)
Injury, poisoning and procedural complications
Foot fracture	1/252 (0.4%)		0/278 (0%)
Injury	1/252 (0.4%)		0/278 (0%)
Rib fracture	1/252 (0.4%)		0/278 (0%)
Ligament sprain	0/252 (0%)		1/278 (0.4%)
Limb injury	0/252 (0%)		1/278 (0.4%)
Muscle injury	0/252 (0%)		1/278 (0.4%)
Skin injury	0/252 (0%)		1/278 (0.4%)
Thoracic vertebral fracture	0/252 (0%)		1/278 (0.4%)
Tooth injury	0/252 (0%)		1/278 (0.4%)
Metabolism and nutrition disorders
Vitamin B1 deficiency	1/252 (0.4%)		0/278 (0%)
Hyperlipidaemia	0/252 (0%)		1/278 (0.4%)
Hyperuricaemia	0/252 (0%)		1/278 (0.4%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/252 (0.4%)		1/278 (0.4%)
Tenosynovitis	1/252 (0.4%)		0/278 (0%)
Back pain	0/252 (0%)		1/278 (0.4%)
Myofascitis	0/252 (0%)		1/278 (0.4%)
Neck pain	0/252 (0%)		1/278 (0.4%)
Periarthritis	0/252 (0%)		1/278 (0.4%)
Soft tissue disorder	0/252 (0%)		1/278 (0.4%)
Spinal osteoarthritis	0/252 (0%)		2/278 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma	0/252 (0%)		1/278 (0.4%)
Nervous system disorders
Headache	2/252 (0.8%)		4/278 (1.4%)
Dizziness	1/252 (0.4%)		2/278 (0.7%)
Cerebral arteriosclerosis	0/252 (0%)		1/278 (0.4%)
Poor quality sleep	0/252 (0%)		1/278 (0.4%)
Vascular headache	0/252 (0%)		1/278 (0.4%)
Psychiatric disorders
Insomnia	0/252 (0%)		1/278 (0.4%)
Sleep disorder	0/252 (0%)		1/278 (0.4%)
Renal and urinary disorders
Nephrolithiasis	1/252 (0.4%)		0/278 (0%)
Urate nephropathy	1/252 (0.4%)		0/278 (0%)
Glomerulonephritis chronic	0/252 (0%)		1/278 (0.4%)
Proteinuria	0/252 (0%)		1/278 (0.4%)
Reproductive system and breast disorders
Balanoposthitis	1/252 (0.4%)		0/278 (0%)
Dysmenorrhoea	1/252 (0.4%)		0/278 (0%)
Endometrial thickening	1/252 (0.4%)		0/278 (0%)
Menstrual disorder	1/252 (0.4%)		0/278 (0%)
Pelvic fluid collection	1/252 (0.4%)		0/278 (0%)
Breast hyperplasia	0/252 (0%)		2/278 (0.7%)
Respiratory, thoracic and mediastinal disorders
Cough	10/252 (4%)		8/278 (2.9%)
Oropharyngeal pain	6/252 (2.4%)		9/278 (3.2%)
Throat irritation	5/252 (2%)		1/278 (0.4%)
Rhinitis allergic	3/252 (1.2%)		3/278 (1.1%)
Rhinorrhoea	3/252 (1.2%)		0/278 (0%)
Nasal obstruction	2/252 (0.8%)		0/278 (0%)
Pneumonitis	2/252 (0.8%)		1/278 (0.4%)
Asthma	1/252 (0.4%)		2/278 (0.7%)
Bronchiectasis	1/252 (0.4%)		0/278 (0%)
Dysphonia	1/252 (0.4%)		1/278 (0.4%)
Oropharyngeal discomfort	1/252 (0.4%)		0/278 (0%)
Pharyngeal oedema	1/252 (0.4%)		0/278 (0%)
Productive cough	1/252 (0.4%)		4/278 (1.4%)
Tachypnoea	1/252 (0.4%)		0/278 (0%)
Bronchitis chronic	0/252 (0%)		1/278 (0.4%)
Dyspnoea	0/252 (0%)		1/278 (0.4%)
Laryngeal pain	0/252 (0%)		1/278 (0.4%)
Sneezing	0/252 (0%)		1/278 (0.4%)
Sputum increased	0/252 (0%)		1/278 (0.4%)
Skin and subcutaneous tissue disorders
Acne	1/252 (0.4%)		0/278 (0%)
Dermatitis	1/252 (0.4%)		1/278 (0.4%)
Dermatitis allergic	1/252 (0.4%)		1/278 (0.4%)
Drug eruption	1/252 (0.4%)		0/278 (0%)
Eczema	1/252 (0.4%)		1/278 (0.4%)
Urticaria	1/252 (0.4%)		3/278 (1.1%)
Hyperhidrosis	0/252 (0%)		1/278 (0.4%)
Rash	0/252 (0%)		4/278 (1.4%)
Surgical and medical procedures
Tooth extraction	1/252 (0.4%)		1/278 (0.4%)
Vascular disorders
Hypertension	0/252 (0%)		1/278 (0.4%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.