DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults
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
2 other identifiers
interventional
1,600
1 country
169
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Dec 2004
169 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 14, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedMarch 17, 2009
March 1, 2009
November 14, 2005
March 16, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first severe asthma exacerbation
Secondary Outcomes (11)
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)
- +6 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any other significant lung disease other than asthma
- Any disease that might put patients at risk if they participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (169)
Research Site
Stuttgart, Baden-Wurttemberg, Germany
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München, Bavaria, Germany
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Cottbus, Brandenburg, Germany
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Hamburg, Hamburg, Germany
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Frankfurt am Main, Hesse, Germany
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Hanover, Lower Saxony, Germany
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Rostock, Mecklenburg-Vorpommern, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Münster, North Rhine-Westphalia, Germany
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Mainz, Rhineland-Palatinate, Germany
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Saarbrücken, Saarland, Germany
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Dresden, Saxony, Germany
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Halle, Saxony-Anhalt, Germany
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Bad Segeberg, Schleswig-Holstein, Germany
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Berlin, State of Berlin, Germany
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Jena-Maua, Thuringia, Germany
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Amberg, Germany
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Aschaffenburg, Germany
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Auerbach, Germany
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Augsburg, Germany
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Backnang, Germany
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Bad Arolsen, Germany
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Bad Doberan, Germany
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Bad Lippspringe, Germany
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Bad Neuenahr, Germany
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Bad Reichenhall, Germany
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Bad Sessendorf, Germany
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Bayreuth, Germany
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Bensheim, Germany
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Bergisch Gladbach, Germany
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Berlin, Germany
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Bitte Eintragen, Germany
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Bochum, Germany
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Bonn, Germany
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Borna, Germany
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Brake, Germany
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Burg, Germany
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Burgwedel, Germany
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Castrop-Rauxel, Germany
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Chemnitz, Germany
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Cologne, Germany
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Coswig, Germany
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Cottbus, Germany
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Damme, Germany
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Darmstadt, Germany
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Deggendorf, Germany
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Dillingen, Germany
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Dinslaken, Germany
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Dortmund, Germany
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Dresden, Germany
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Dülmen, Germany
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Düsseldorf, Germany
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Eisenach, Germany
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Eisenhüttenstadt, Germany
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Emden, Germany
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Erfurt, Germany
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Erkelenz, Germany
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Eschwege, Germany
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Flensburg, Germany
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Forchheim, Germany
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Frankenthal, Germany
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Frankfurt, Germany
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Freiberg, Germany
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Freiburg im Breisgau, Germany
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Freising, Germany
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Fulda, Germany
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Fürstenwalde, Germany
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Fürth, Germany
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Gelsenkirchen, Germany
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Giessen, Germany
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Gotha, Germany
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Göppingen, Germany
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Günzburg, Germany
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Gütersloh, Germany
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Hagen, Germany
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Halle, Germany
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Hamburg, Germany
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Hamm, Germany
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Hanover, Germany
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Harpstedt, Germany
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Hartha, Germany
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Heidelberg, Germany
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Heilbronn, Germany
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Homburg-Saar, Germany
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Hoyerswerda, Germany
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Iserloh, Germany
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Kamen, Germany
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Kamenz, Germany
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Kamp-Lintfort, Germany
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Karlsruhe, Germany
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Kassel, Germany
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Kaufbeuren, Germany
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Kempten, Germany
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Kiel, Germany
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Kitzingen, Germany
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Koblenz, Germany
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Krefeld, Germany
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Kronach, Germany
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Landsberg, Germany
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Leipzig, Germany
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Leonberg, Germany
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Leverkusen, Germany
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Loerrach, Germany
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Ludwigsburg, Germany
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Lübeck, Germany
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Lüneburg, Germany
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Magdeburg, Germany
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Mainaschaff, Germany
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Mainz, Germany
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Marburg, Germany
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Markkleeberg, Germany
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Memmingen, Germany
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Moers, Germany
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Mönchengladbach, Germany
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Mühlhausen, Germany
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München, Germany
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Neubrandenburg, Germany
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Neuss, Germany
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Neuwied, Germany
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Niesky, Germany
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Nordhausen, Germany
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Oberhausen, Germany
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Oranienburg, Germany
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Oschersleben, Germany
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Paderborn, Germany
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Passau, Germany
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Peine, Germany
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Pforzheim, Germany
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Pinneberg, Germany
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Potsdam, Germany
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Ratingen, Germany
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Recklinghausen, Germany
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Regensburg, Germany
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Reutlingen, Germany
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Rheine, Germany
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Rodenbach, Germany
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Rostock, Germany
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Rottweil, Germany
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Rudolstadt, Germany
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Saalfeld, Germany
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Saarbrücken, Germany
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Saarlouis, Germany
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Salzgitter, Germany
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Sangerhausen, Germany
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Schleswig, Germany
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Schwabach, Germany
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Schwäbisch Gmünd, Germany
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Schwerin, Germany
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Siegen, Germany
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Simmern, Germany
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Sindelfingen, Germany
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Singen, Germany
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Solingen, Germany
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Stade, Germany
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Stadthagen, Germany
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Steinhagen, Germany
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Stuttgart, Germany
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Trier, Germany
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Ulm, Germany
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Uttenreuth, Germany
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Wardenburg, Germany
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Wedel, Germany
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Weinheim, Germany
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Weyhe, Germany
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Witten, Germany
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Worpswede, Germany
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Würzburg, Germany
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Zerbst, Germany
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Zwickau, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heinrich Worth, MD
Klinikum Fürth
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 14, 2005
First Posted
November 15, 2005
Study Start
December 1, 2004
Study Completion
May 1, 2006
Last Updated
March 17, 2009
Record last verified: 2009-03