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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252863
• Other study ID #: D5890L00011
• Secondary ID: DESOLO
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2005
• Last updated: March 16, 2009
• Start date: December 2004
• Est. completion date: May 2006

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Symbicort, used twice daily (b.i.d) and as needed (prn)

• Budesonide Turbuhaler 200 µg

• Fluticasone Discus 250 µg

• Formoterol Turbuhaler 4.5 µg

• Terbutaline Turbuhaler 0.5 mg

• Salbutamol pressurized metered dose inhaler (pMDI) 100 µg

• Salmeterol Discus 50 µg

• Budesonide/Formoterol Turbuhaler 160/4.5 µg

• Fluticasone/Salmeterol Discus 250/50 µg

• Fluticasone/Salmeterol Discus 500/50 µg

• Theophylline 200 mg

• Theophylline 300 mg

• Singulair 10 mg

Locations

Country	Name	City	State
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 Segeberg	Schleswig-Holstein
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	Coswig
Germany	Research Site	Cottbus
Germany	Research Site	Cottbus	Brandenburg
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	Dresden	Sachsen
Germany	Research Site	Dülmen
Germany	Research Site	Düsseldorf
Germany	Research Site	Düsseldorf	Nordrhein-Westfalen
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	Frankfurt	Hessen
Germany	Research Site	Freiberg
Germany	Research Site	Freiburg
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	Göppingen
Germany	Research Site	Gotha
Germany	Research Site	Günzburg
Germany	Research Site	Gütersloh
Germany	Research Site	Hagen
Germany	Research Site	Halle
Germany	Research Site	Halle	Sachsen-Anhalt
Germany	Research Site	Hamburg
Germany	Research Site	Hamm
Germany	Research Site	Hannover
Germany	Research Site	Hannover	Niedersachsen
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	Jena-Maua	Thüringen
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	Köln
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	Lörrach
Germany	Research Site	Lübeck
Germany	Research Site	Ludwigsburg
Germany	Research Site	Lüneburg
Germany	Research Site	Magdeburg
Germany	Research Site	Mainaschaff
Germany	Research Site	Mainz
Germany	Research Site	Mainz	Rheinland-Pfalz
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	München	Bayern
Germany	Research Site	Münster	Nordrhein-Westfalen
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	Rostock	Mecklenburg-Vorpommern
Germany	Research Site	Rottweil
Germany	Research Site	Rudolstadt
Germany	Research Site	Saalfeld
Germany	Research Site	Saarbrücken
Germany	Research Site	Saarbrücken	Saarland
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	Stuttgart	Baden-Württemberg
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

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