DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults
NCT00252863 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1600
Last updated 2009-03-17
Summary
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Heinrich Worth, MD · Klinikum Fürth
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-12-31
- Completion
- 2006-05-31
Countries
- Germany
Study Locations
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