A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma

Study Overview
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Brief Summary
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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.

Detailed Description
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A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.

Official Title
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A Comparison of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5mg, 1 Inhalation Two Times a Day (b.i.d.) Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults a -26-week, Randomized, Open-label, Parallel-group, Multicentre Study

Conditions
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Asthma

Intervention / Treatment
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* Drug: Symbicort TBH - Turbuhaler
* Drug: beta-II-agonist, inhale steroid


Participation Criteria
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Eligibility Criteria
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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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symbicort<br>Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed) | Drug: Symbicort TBH - Turbuhaler<br>* Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)<br>|
| Experimental: Conventional BP<br>Conventional Best Practice for Treatment of Asthma | Drug: beta-II-agonist, inhale steroid<br>* 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<br>* Other names: Symbicort 160/4.5 mcg/60-120 dosage, 320/9mcg/60 dosage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Severe Asthma Exacerbation | Time to severe exacerbation among patients | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symbicort, Turbuhaler, Persistent Asthma