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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.
A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symbicort | Experimental | Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed) |
|
| Conventional BP | Experimental | Conventional Best Practice for Treatment of Asthma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbicort TBH - Turbuhaler | Drug | Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Severe Asthma Exacerbation | Time to severe exacerbation among patients | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Severe Asthma Exacerbations | Total number of severe asthma exacerbations per treatment group | 26 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeynep Misirligil | Ankara Univ. Med. Fac, Chest Disease Dept | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ankara | Turkey (Türkiye) | ||||
| Research Site |
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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)
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| ID | Title | Description |
|---|---|---|
| FG000 | Symbicort | Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need) |
| FG001 | Conventional BP | Conventional Best Practice for Treatment of asthma |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| beta-II-agonist, inhale steroid | Drug | 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 |
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| Baseline and 26 weeks |
| Mean Use of As-needed Medication Per Day During Treatment Period | Mean use of as-needed medication per day during treatment period | Daily recording during the treatment period of 26 weeks |
| Antalya |
| Turkey (Türkiye) |
| Research Site | Bursa | Turkey (Türkiye) |
| Research Site | Denizli | Turkey (Türkiye) |
| Research Site | Diyarbakır | Turkey (Türkiye) |
| Research Site | Edirne | Turkey (Türkiye) |
| Research Site | Eski?ehir | Turkey (Türkiye) |
| Research Site | Istanbul | Turkey (Türkiye) |
| Research Site | Izmir | Turkey (Türkiye) |
| Research Site | Kocaeli | Turkey (Türkiye) |
| Research Site | Malatya | Turkey (Türkiye) |
| Research Site | Manisa | Turkey (Türkiye) |
| Research Site | Mersin | Turkey (Türkiye) |
| Research Site | Samsun | Turkey (Türkiye) |
| Research Site | Zonguldak | Turkey (Türkiye) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Symbicort | Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need) |
| BG001 | Conventional BP | Conventional Best Practice for Treatment of asthma |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to First Severe Asthma Exacerbation | Time to severe exacerbation among patients | Posted | Sep 2009 | Mean | Standard Deviation | days | 26 weeks |
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| Secondary | Number of Severe Asthma Exacerbations | Total number of severe asthma exacerbations per treatment group | Posted | Number | Severe Exacerbations | 26 weeks |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 26 weeks |
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| Secondary | Mean Use of As-needed Medication Per Day During Treatment Period | Mean use of as-needed medication per day during treatment period | 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. | Posted | Mean | Standard Deviation | inhalations per day | Daily recording during the treatment period of 26 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Symbicort | Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need) | 2 | 209 | 0 | 209 | ||
| EG001 | Conventional BP | Conventional Best Practice for Treatment of asthma | 2 | 221 | 0 | 221 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Lower Limb Fracture | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | +44 1509 645895 | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068759 | Formoterol Fumarate |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| Male |
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