DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines.

Official Title
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A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 µg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-Week, Randomised, Open-Label, Parallel-Group, Multicentre Study

Conditions
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Asthma

Intervention / Treatment
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* Drug: Symbicort, used twice daily (b.i.d) and as needed (prn)
* Drug: Budesonide Turbuhaler 200 µg
* Drug: Fluticasone Discus 250 µg
* Drug: Formoterol Turbuhaler 4.5 µg
* Drug: Terbutaline Turbuhaler 0.5 mg
* Drug: Salbutamol pressurized metered dose inhaler (pMDI) 100 µg
* Drug: Salmeterol Discus 50 µg
* Drug: Budesonide/Formoterol Turbuhaler 160/4.5 µg
* Drug: Fluticasone/Salmeterol Discus 250/50 µg
* Drug: Fluticasone/Salmeterol Discus 500/50 µg
* Drug: Theophylline 200 mg
* Drug: Theophylline 300 mg
* Drug: Singulair 10 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with asthma, either well-controlled on a regular therapy with a combination of long-acting beta-agonists and inhaled corticosteroids or symptomatic on therapy with inhaled corticosteroids alone. Exclusion Criteria: Any other significant lung disease other than asthma Any disease that might put patients at risk if they participate 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

| Intervention/Treatment |
| --- |
|Drug: Symbicort, used twice daily (b.i.d) and as needed (prn)|nan|
|Drug: Budesonide Turbuhaler 200 µg|nan|
|Drug: Fluticasone Discus 250 µg|nan|
|Drug: Formoterol Turbuhaler 4.5 µg|nan|
|Drug: Terbutaline Turbuhaler 0.5 mg|nan|
|Drug: Salbutamol pressurized metered dose inhaler (pMDI) 100 µg|nan|
|Drug: Salmeterol Discus 50 µg|nan|
|Drug: Budesonide/Formoterol Turbuhaler 160/4.5 µg|nan|
|Drug: Fluticasone/Salmeterol Discus 250/50 µg|nan|
|Drug: Fluticasone/Salmeterol Discus 500/50 µg|nan|
|Drug: Theophylline 200 mg|nan|
|Drug: Theophylline 300 mg|nan|
|Drug: Singulair 10 mg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first severe asthma exacerbation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of severe asthma exacerbations |  |  | 
| Mean use of as-needed medication |  |  | 
| Change in forced expiratory volume in 1 second (FEV1) from the end of run-in to the end of the study period |  |  | 
| Prescribed asthma medication during the treatment period |  |  | 
| Asthma Control Questionnaire (ACQ) |  |  | 
| Patient's satisfaction with the treatment question |  |  | 
| Health care contacts |  |  | 
| Asthma medication |  |  | 
| Time lost from paid and unpaid work |  |  | 
| Serious adverse events (SAEs) |  |  | 
| Discontinuations due to adverse events (AEs) |  |  |