Asthma
Conditions
Keywords
Asthma
Brief summary
The purpose of the study is to evaluate the satisfaction level of patients using the Symbicort SMART approach for their asthma management.
Interventions
DRUGSymbicort Turbuhaler 160/4.5
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of asthma for past 6 months and treated with inhaled glucocorticosteroids for at least 3 months. * Patients who asthma is classified as uncontrolled or partially controlled as defined by GINA 2006 guidelines.
Exclusion criteria
* Patients already on Symbicort SMART treatment. * Patients who has respiratory tract infection 30 days before study enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART | 6 months after each patient was initially treated with Symbicort SMART | Difference/change in SATQ score between baseline and mean of 3 months and 6 months after SMART treatment as analysed by paired t-test. SATQ is a patient reported questionnaire which consists of 26 questions and scored to a scale of 1-7, the higher score indicating a greater level of satisfaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART | 6 months after each patient was initially treated with Symbicort SMART | Difference/change in ACQ-5 scores between baseline and mean of 3 months and 6 months after SMART treatment. ACQ-5 is a 5 question patient reported outcome measuring level of asthma control during the past 7 days and it is scored on scale of 0-6. 0 indicates no symptoms and 6 represents severe symptoms |
Countries
Malaysia
Participant flow
Recruitment details
201 patients were recruited from 10 government hospital based outpatient clinics from Dec 2007 until May 2008
Participants by arm
| Arm | Count |
|---|---|
| Symbicort 160/4.5 Turbuhaler Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever | 201 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Protocol Violation | 9 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Symbicort 160/4.5 Turbuhaler |
|---|---|
| Age Continuous Mean Age | 46.73 years STANDARD_DEVIATION 12.31 |
| Sex: Female, Male Female | 155 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 70 / — |
| serious Total, serious adverse events | 17 / — |
Outcome results
Primary
Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART
Difference/change in SATQ score between baseline and mean of 3 months and 6 months after SMART treatment as analysed by paired t-test. SATQ is a patient reported questionnaire which consists of 26 questions and scored to a scale of 1-7, the higher score indicating a greater level of satisfaction
Time frame: 6 months after each patient was initially treated with Symbicort SMART
Population: 201 participants were recruited but statistical analysis was completed for 195 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort 160/4.5 Turbuhaler | Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART | 0.37 Scores on a scale | Standard Deviation 0.73 |
Secondary
Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART
Difference/change in ACQ-5 scores between baseline and mean of 3 months and 6 months after SMART treatment. ACQ-5 is a 5 question patient reported outcome measuring level of asthma control during the past 7 days and it is scored on scale of 0-6. 0 indicates no symptoms and 6 represents severe symptoms
Time frame: 6 months after each patient was initially treated with Symbicort SMART
Population: 201 participants were recruited but statistical analysis was completed for 195 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort 160/4.5 Turbuhaler | Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART | -0.97 scores on a scale | Standard Deviation 1.22 |