Asthma
Conditions
Keywords
Symbicort, Turbuhaler, Persistent Asthma
Brief summary
The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma.
Detailed description
A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.
Interventions
DRUGSymbicort TBH - Turbuhaler
Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
DRUGbeta-II-agonist, inhale steroid
Salbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenous(IV),5mgx10 ampule(amp) Ventolin inhaler (inh) 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent form. If the patient cannot read and write, verbal consent from the patient is required. * Ability to read and write in Turkish * Female or male outpatients aged 18 years * Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition * Prescribed inhaled glucocorticosteroid (GCS) at a dose of 320mg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1 * Either: daily maintenance treatment with both inhaled GCS and long-acting b2-agonist (LABA) or daily treatment with inhaled GCS alone (i.e. without LABA); and a history of suboptimal asthma control the month prior to enrollment as judged by the investigator; and use of 3 Peak Expiratory Flow inhalations ofas needed medication for symptom relief during the last 7 days before enrollment
Exclusion criteria
* Previous treatment with Symbicort Single inhaler Therapy * Use of any b-blocking agent, including eye drops * Use of oral GCS as maintenance treatment * Known or suspected hypersensitivity to study therapy or excipients * A history of smoking 10 pack years * Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator * Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Severe Asthma Exacerbation | 26 weeks | Time to severe exacerbation among patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Severe Asthma Exacerbations | 26 weeks | Total number of severe asthma exacerbations per treatment group |
| Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score | Baseline and 26 weeks | Quality-of-Life assessment; grouped in four domains;activity limitation, symptoms, emotional function and exposure to environmental stimuli, using with a scale from 1 to 7 where 1 represents the greatest possible impairment and 7 represents the least impairment. |
| Mean Use of As-needed Medication Per Day During Treatment Period | Daily recording during the treatment period of 26 weeks | Mean use of as-needed medication per day during treatment period |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
FSI: LSI: LSO: Center type: Research and Training Host, Chest Medicine and Internal Medicine 23 Clinics. Number of enrolled subjects: 432, randomized: 430, completed patients: 344 ( Arm A:165, Arm B 179)
Participants by arm
| Arm | Count |
|---|---|
| Symbicort Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need) | 209 |
| Conventional BP Conventional Best Practice for Treatment of asthma | 221 |
| Total | 430 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Investigator Moved | 3 | 0 |
| Overall Study | Lost to Follow-up | 25 | 31 |
| Overall Study | Pregnancy | 2 | 2 |
| Overall Study | Protocol Violation | 5 | 1 |
| Overall Study | Treatment Failure | 0 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | Symbicort | Conventional BP | Total |
|---|---|---|---|
| Age Continuous | 44.28 years STANDARD_DEVIATION 12.09 | 45.17 years STANDARD_DEVIATION 12.71 | 44.7 years STANDARD_DEVIATION 12.4 |
| Sex: Female, Male Female | 157 Participants | 179 Participants | 336 Participants |
| Sex: Female, Male Male | 52 Participants | 42 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 209 | 0 / 221 |
| serious Total, serious adverse events | 2 / 209 | 2 / 221 |
Outcome results
Primary
Time to First Severe Asthma Exacerbation
Time to severe exacerbation among patients
Time frame: 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Time to First Severe Asthma Exacerbation | 120.3 days | Standard Deviation 47 |
| Conventional Best Practice (BP) | Time to First Severe Asthma Exacerbation | 103.7 days | Standard Deviation 32.7 |
Secondary
Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score
Quality-of-Life assessment; grouped in four domains;activity limitation, symptoms, emotional function and exposure to environmental stimuli, using with a scale from 1 to 7 where 1 represents the greatest possible impairment and 7 represents the least impairment.
Time frame: Baseline and 26 weeks
Population: ITT analysis was performed. Being in line with the analysis description population and due to the description of the variable. This patient-reported outcome variable could only be calculated for patients who have baseline and visit 4 AQLQ data. The AQLQ was not filled in by all enrolled patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score | 3.98 Units on a scale | Standard Deviation 1.12 |
| Conventional Best Practice (BP) | Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score | 3.97 Units on a scale | Standard Deviation 1.15 |
Secondary
Mean Use of As-needed Medication Per Day During Treatment Period
Mean use of as-needed medication per day during treatment period
Time frame: Daily recording during the treatment period of 26 weeks
Population: ITT analysis was performed. Being in line with the analysis description population and due to description of the variable which was based on the patient's estimate, this variable could only be calculated of the patients who had recorded at least one estimate on their dairies they had been asked to return to the investigator at the study visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Mean Use of As-needed Medication Per Day During Treatment Period | 0.91 inhalations per day | Standard Deviation 7.6 |
| Conventional Best Practice (BP) | Mean Use of As-needed Medication Per Day During Treatment Period | 0.68 inhalations per day | Standard Deviation 5.7 |
Secondary
Number of Severe Asthma Exacerbations
Total number of severe asthma exacerbations per treatment group
Time frame: 26 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Symbicort | Number of Severe Asthma Exacerbations | 10 Severe Exacerbations |
| Conventional Best Practice (BP) | Number of Severe Asthma Exacerbations | 10 Severe Exacerbations |