Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DESOLO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first severe asthma exacerbation |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Heinrich Worth, MD | Klinikum Fürth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Stuttgart | Baden-Wurttemberg | Germany | |||
| Research Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Drug |
| 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) |
| München |
| Bavaria |
| Germany |
| Research Site | Cottbus | Brandenburg | Germany |
| Research Site | Hamburg | Free and Hanseatic City of Hamburg | Germany |
| Research Site | Frankfurt am Main | Hesse | Germany |
| Research Site | Hanover | Lower Saxony | Germany |
| Research Site | Rostock | Mecklenburg-Vorpommern | Germany |
| Research Site | Düsseldorf | North Rhine-Westphalia | Germany |
| Research Site | Münster | North Rhine-Westphalia | Germany |
| Research Site | Mainz | Rhineland-Palatinate | Germany |
| Research Site | Saarbrücken | Saarland | Germany |
| Research Site | Dresden | Saxony | Germany |
| Research Site | Halle | Saxony-Anhalt | Germany |
| Research Site | Bad Segeberg | Schleswig-Holstein | Germany |
| Research Site | Berlin | State of Berlin | Germany |
| Research Site | Jena-Maua | Thuringia | Germany |
| Research Site | Amberg | Germany |
| Research Site | Aschaffenburg | Germany |
| Research Site | Auerbach | Germany |
| Research Site | Augsburg | Germany |
| Research Site | Backnang | Germany |
| Research Site | Bad Arolsen | Germany |
| Research Site | Bad Doberan | Germany |
| Research Site | Bad Lippspringe | Germany |
| Research Site | Bad Neuenahr | Germany |
| Research Site | Bad Reichenhall | Germany |
| Research Site | Bad Sessendorf | Germany |
| Research Site | Bayreuth | Germany |
| Research Site | Bensheim | Germany |
| Research Site | Bergisch Gladbach | Germany |
| Research Site | Berlin | Germany |
| Research Site | Bitte Eintragen | Germany |
| Research Site | Bochum | Germany |
| Research Site | Bonn | Germany |
| Research Site | Borna | Germany |
| Research Site | Brake | Germany |
| Research Site | Burg | Germany |
| Research Site | Burgwedel | Germany |
| Research Site | Castrop-Rauxel | Germany |
| Research Site | Chemnitz | Germany |
| Research Site | Cologne | Germany |
| Research Site | Coswig | Germany |
| Research Site | Cottbus | Germany |
| Research Site | Damme | Germany |
| Research Site | Darmstadt | Germany |
| Research Site | Deggendorf | Germany |
| Research Site | Dillingen | Germany |
| Research Site | Dinslaken | Germany |
| Research Site | Dortmund | Germany |
| Research Site | Dresden | Germany |
| Research Site | Dülmen | Germany |
| Research Site | Düsseldorf | Germany |
| Research Site | Eisenach | Germany |
| Research Site | Eisenhüttenstadt | Germany |
| Research Site | Emden | Germany |
| Research Site | Erfurt | Germany |
| Research Site | Erkelenz | Germany |
| Research Site | Eschwege | Germany |
| Research Site | Flensburg | Germany |
| Research Site | Forchheim | Germany |
| Research Site | Frankenthal | Germany |
| Research Site | Frankfurt | Germany |
| Research Site | Freiberg | Germany |
| Research Site | Freiburg im Breisgau | Germany |
| Research Site | Freising | Germany |
| Research Site | Fulda | Germany |
| Research Site | Fürstenwalde | Germany |
| Research Site | Fürth | Germany |
| Research Site | Gelsenkirchen | Germany |
| Research Site | Giessen | Germany |
| Research Site | Gotha | Germany |
| Research Site | Göppingen | Germany |
| Research Site | Günzburg | Germany |
| Research Site | Gütersloh | Germany |
| Research Site | Hagen | Germany |
| Research Site | Halle | Germany |
| Research Site | Hamburg | Germany |
| Research Site | Hamm | Germany |
| Research Site | Hanover | Germany |
| Research Site | Harpstedt | Germany |
| Research Site | Hartha | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Heilbronn | Germany |
| Research Site | Homburg-Saar | Germany |
| Research Site | Hoyerswerda | Germany |
| Research Site | Iserloh | Germany |
| Research Site | Kamen | Germany |
| Research Site | Kamenz | Germany |
| Research Site | Kamp-Lintfort | Germany |
| Research Site | Karlsruhe | Germany |
| Research Site | Kassel | Germany |
| Research Site | Kaufbeuren | Germany |
| Research Site | Kempten | Germany |
| Research Site | Kiel | Germany |
| Research Site | Kitzingen | Germany |
| Research Site | Koblenz | Germany |
| Research Site | Krefeld | Germany |
| Research Site | Kronach | Germany |
| Research Site | Landsberg | Germany |
| Research Site | Leipzig | Germany |
| Research Site | Leonberg | Germany |
| Research Site | Leverkusen | Germany |
| Research Site | Loerrach | Germany |
| Research Site | Ludwigsburg | Germany |
| Research Site | Lübeck | Germany |
| Research Site | Lüneburg | Germany |
| Research Site | Magdeburg | Germany |
| Research Site | Mainaschaff | Germany |
| Research Site | Mainz | Germany |
| Research Site | Marburg | Germany |
| Research Site | Markkleeberg | Germany |
| Research Site | Memmingen | Germany |
| Research Site | Moers | Germany |
| Research Site | Mönchengladbach | Germany |
| Research Site | Mühlhausen | Germany |
| Research Site | München | Germany |
| Research Site | Neubrandenburg | Germany |
| Research Site | Neuss | Germany |
| Research Site | Neuwied | Germany |
| Research Site | Niesky | Germany |
| Research Site | Nordhausen | Germany |
| Research Site | Oberhausen | Germany |
| Research Site | Oranienburg | Germany |
| Research Site | Oschersleben | Germany |
| Research Site | Paderborn | Germany |
| Research Site | Passau | Germany |
| Research Site | Peine | Germany |
| Research Site | Pforzheim | Germany |
| Research Site | Pinneberg | Germany |
| Research Site | Potsdam | Germany |
| Research Site | Ratingen | Germany |
| Research Site | Recklinghausen | Germany |
| Research Site | Regensburg | Germany |
| Research Site | Reutlingen | Germany |
| Research Site | Rheine | Germany |
| Research Site | Rodenbach | Germany |
| Research Site | Rostock | Germany |
| Research Site | Rottweil | Germany |
| Research Site | Rudolstadt | Germany |
| Research Site | Saalfeld | Germany |
| Research Site | Saarbrücken | Germany |
| Research Site | Saarlouis | Germany |
| Research Site | Salzgitter | Germany |
| Research Site | Sangerhausen | Germany |
| Research Site | Schleswig | Germany |
| Research Site | Schwabach | Germany |
| Research Site | Schwäbisch Gmünd | Germany |
| Research Site | Schwerin | Germany |
| Research Site | Siegen | Germany |
| Research Site | Simmern | Germany |
| Research Site | Sindelfingen | Germany |
| Research Site | Singen | Germany |
| Research Site | Solingen | Germany |
| Research Site | Stade | Germany |
| Research Site | Stadthagen | Germany |
| Research Site | Steinhagen | Germany |
| Research Site | Stuttgart | Germany |
| Research Site | Trier | Germany |
| Research Site | Ulm | Germany |
| Research Site | Uttenreuth | Germany |
| Research Site | Wardenburg | Germany |
| Research Site | Wedel | Germany |
| Research Site | Weinheim | Germany |
| Research Site | Weyhe | Germany |
| Research Site | Witten | Germany |
| Research Site | Worpswede | Germany |
| Research Site | Würzburg | Germany |
| Research Site | Zerbst | Germany |
| Research Site | Zwickau | Germany |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D006301 | Health Services Needs and Demand |
| D019819 | Budesonide |
| D000068298 | Fluticasone |
| D013806 | Theophylline |
| C093875 | montelukast |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided