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

Study Overview
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Brief Summary
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Symbicort (Budesonide/Formoterol)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Symbicort Turbuhaler 160/4.5 µg delivered dose | Drug: Symbicort (Budesonide/Formoterol)<br>* 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<br>* Other names: Symbicort;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline and 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symbicort SMART