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

Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy (SMART) in Asthma Patients Across Asia: SMARTASIA

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00939341

Acronym

SMARTASIA

Enrollment

862

Registered

2009-07-15

Start date

2009-07-31

Completion date

2010-08-31

Last updated

2012-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Symbicort SMART

Brief summary

The purpose of this study is to compare whether Symbicort Maintenance & Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation.

Interventions

DRUGSymbicort (Budesonide/Formoterol)

Turbuhaler 160/4.5 µg delivered dose, twice daily (one inhalation in the morning and one inhalation in the evening) and as need (prn) in response to symptoms

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Provision of signed informed consent * Asthma diagnosis at least 6 months before visit 1 of study * Patients who have reversible airway obstruction continuous asthma treatment except Symbicort at least within 4 weeks before visit 1 of study

Exclusion criteria

* Known or suspected allergy to active ingredients of study medication or excipients * Use of oral, rectal or parenteral glucocorticosteroids 30 days before visit 1 of study * Smoking, current or previous with a smoking history of ≥ 10 pack years

Design outcomes

Primary

Measure	Time frame	Description
Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level	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).

Secondary

Measure	Time frame	Description
Change in Overall ACQ(5) Score From Baseline at Country Level (India)	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).
Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)	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).
Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)	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).
Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)	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).
Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline	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)
Change in AQLQ (S) Domain (Symptom) Scores From Baseline	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).
Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline	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)
Change in ACQ(5) Score From Baseline at Country Level (China)	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).
Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline	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)
Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Day-time Reliever Medication From run-in Period	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.
Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Night-time Reliever Medication From run-in Period	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.
Study Medication Use (Maintenance and Reliever) in Diary Cards - Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period	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
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	Baseline and 12 weeks	The mean percentage of days during treatment period participants used ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day
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	Baseline and 12 weeks	The mean percentage of days during treatment period participants used ≥ 5 inhalations of Symbicort® 160µg/4.5µg in a day
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	Baseline and 12 weeks	The mean percentage of days during treatment period participants used ≥ 9 inhalations of Symbicort® 160µg/4.5µg in a day
Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline	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)

Countries

China, India, Indonesia, Taiwan, Thailand

Participant flow

Recruitment details

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

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

Participants by arm

Arm	Count
Symbicort Turbuhaler 160/4.5 µg delivered dose	862
Total	862

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	15
Overall Study	Incorrect enrolment	8
Overall Study	Lost to Follow-up	23
Overall Study	Pregnancy	1
Overall Study	Protocol Violation	6
Overall Study	Withdrawal by Subject	13

Baseline characteristics

Characteristic	Symbicort Turbuhaler
Age Continuous All Participants	13.7 Years STANDARD_DEVIATION 44.7
Sex: Female, Male Female	455 Participants
Sex: Female, Male Male	407 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 862
serious Total, serious adverse events	12 / 862

Outcome results

Primary

Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level

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).