Clinical trial NCT00252863: DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to first severe asthma exacerbation
Secondary outcomes:
measure: Number of severe asthma exacerbations
measure: Mean use of as-needed medication
measure: Change in forced expiratory volume in 1 second (FEV1) from the end of run-in to the end of the study period
measure: Prescribed asthma medication during the treatment period
measure: Asthma Control Questionnaire (ACQ)
measure: Patient's satisfaction with the treatment question
measure: Health care contacts
measure: Asthma medication
measure: Time lost from paid and unpaid work
measure: Serious adverse events (SAEs)
measure: Discontinuations due to adverse events (AEs)
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Research Site
state: Baden-Württemberg
city: München
country: Germany
facility: Research Site
state: Bayern
city: Cottbus
country: Germany
facility: Research Site
state: Brandenburg
city: Frankfurt
country: Germany
facility: Research Site
state: Hessen
city: Rostock
country: Germany
facility: Research Site
state: Mecklenburg-Vorpommern
city: Hannover
country: Germany
facility: Research Site
state: Niedersachsen
city: Düsseldorf
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Research Site
state: Rheinland-Pfalz
city: Saarbrücken
country: Germany
facility: Research Site
state: Saarland
city: Halle
country: Germany
facility: Research Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Research Site
state: Sachsen
city: Bad Segeberg
country: Germany
facility: Research Site
state: Schleswig-Holstein
city: Jena-Maua
country: Germany
facility: Research Site
state: Thüringen
city: Amberg
country: Germany
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Auerbach
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Backnang
country: Germany
facility: Research Site
city: Bad Arolsen
country: Germany
facility: Research Site
city: Bad Doberan
country: Germany
facility: Research Site
city: Bad Lippspringe
country: Germany
facility: Research Site
city: Bad Neuenahr
country: Germany
facility: Research Site
city: Bad Reichenhall
country: Germany
facility: Research Site
city: Bad Sessendorf
country: Germany
facility: Research Site
city: Bayreuth
country: Germany
facility: Research Site
city: Bensheim
country: Germany
facility: Research Site
city: Bergisch Gladbach
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bitte Eintragen
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Borna
country: Germany
facility: Research Site
city: Brake
country: Germany
facility: Research Site
city: Burgwedel
country: Germany
facility: Research Site
city: Burg
country: Germany
facility: Research Site
city: Castrop-Rauxel
country: Germany
facility: Research Site
city: Chemnitz
country: Germany
facility: Research Site
city: Coswig
country: Germany
facility: Research Site
city: Cottbus
country: Germany
facility: Research Site
city: Damme
country: Germany
facility: Research Site
city: Darmstadt
country: Germany
facility: Research Site
city: Deggendorf
country: Germany
facility: Research Site
city: Dillingen
country: Germany
facility: Research Site
city: Dinslaken
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Dülmen
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Eisenach
country: Germany
facility: Research Site
city: Eisenhüttenstadt
country: Germany
facility: Research Site
city: Emden
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Erkelenz
country: Germany
facility: Research Site
city: Eschwege
country: Germany
facility: Research Site
city: Flensburg
country: Germany
facility: Research Site
city: Forchheim
country: Germany
facility: Research Site
city: Frankenthal
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Freiberg
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Freising
country: Germany
facility: Research Site
city: Fulda
country: Germany
facility: Research Site
city: Fürstenwalde
country: Germany
facility: Research Site
city: Fürth
country: Germany
facility: Research Site
city: Gelsenkirchen
country: Germany
facility: Research Site
city: Gießen
country: Germany
facility: Research Site
city: Gotha
country: Germany
facility: Research Site
city: Göppingen
country: Germany
facility: Research Site
city: Günzburg
country: Germany
facility: Research Site
city: Gütersloh
country: Germany
facility: Research Site
city: Hagen
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamm
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Harpstedt
country: Germany
facility: Research Site
city: Hartha
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Heilbronn
country: Germany
facility: Research Site
city: Homburg-Saar
country: Germany
facility: Research Site
city: Hoyerswerda
country: Germany
facility: Research Site
city: Iserloh
country: Germany
facility: Research Site
city: Kamenz
country: Germany
facility: Research Site
city: Kamen
country: Germany
facility: Research Site
city: Kamp-Lintfort
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Kaufbeuren
country: Germany
facility: Research Site
city: Kempten
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Kitzingen
country: Germany
facility: Research Site
city: Koblenz
country: Germany
facility: Research Site
city: Krefeld
country: Germany
facility: Research Site
city: Kronach
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Landsberg
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leonberg
country: Germany
facility: Research Site
city: Leverkusen
country: Germany
facility: Research Site
city: Ludwigsburg
country: Germany
facility: Research Site
city: Lörrach
country: Germany
facility: Research Site
city: Lübeck
country: Germany
facility: Research Site
city: Lüneburg
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Mainaschaff
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Markkleeberg
country: Germany
facility: Research Site
city: Memmingen
country: Germany
facility: Research Site
city: Moers
country: Germany
facility: Research Site
city: Mönchengladbach
country: Germany
facility: Research Site
city: Mühlhausen
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Neubrandenburg
country: Germany
facility: Research Site
city: Neuss
country: Germany
facility: Research Site
city: Neuwied
country: Germany
facility: Research Site
city: Niesky
country: Germany
facility: Research Site
city: Nordhausen
country: Germany
facility: Research Site
city: Oberhausen
country: Germany
facility: Research Site
city: Oranienburg
country: Germany
facility: Research Site
city: Oschersleben
country: Germany
facility: Research Site
city: Paderborn
country: Germany
facility: Research Site
city: Passau
country: Germany
facility: Research Site
city: Peine
country: Germany
facility: Research Site
city: Pforzheim
country: Germany
facility: Research Site
city: Pinneberg
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Ratingen
country: Germany
facility: Research Site
city: Recklinghausen
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Reutlingen
country: Germany
facility: Research Site
city: Rheine
country: Germany
facility: Research Site
city: Rodenbach
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Rottweil
country: Germany
facility: Research Site
city: Rudolstadt
country: Germany
facility: Research Site
city: Saalfeld
country: Germany
facility: Research Site
city: Saarbrücken
country: Germany
facility: Research Site
city: Saarlouis
country: Germany
facility: Research Site
city: Salzgitter
country: Germany
facility: Research Site
city: Sangerhausen
country: Germany
facility: Research Site
city: Schleswig
country: Germany
facility: Research Site
city: Schwabach
country: Germany
facility: Research Site
city: Schwerin
country: Germany
facility: Research Site
city: Schwäbisch Gmünd
country: Germany
facility: Research Site
city: Siegen
country: Germany
facility: Research Site
city: Simmern
country: Germany
facility: Research Site
city: Sindelfingen
country: Germany
facility: Research Site
city: Singen
country: Germany
facility: Research Site
city: Solingen
country: Germany
facility: Research Site
city: Stade
country: Germany
facility: Research Site
city: Stadthagen
country: Germany
facility: Research Site
city: Steinhagen
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Trier
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Uttenreuth
country: Germany
facility: Research Site
city: Wardenburg
country: Germany
facility: Research Site
city: Wedel
country: Germany
facility: Research Site
city: Weinheim
country: Germany
facility: Research Site
city: Weyhe
country: Germany
facility: Research Site
city: Witten
country: Germany
facility: Research Site
city: Worpswede
country: Germany
facility: Research Site
city: Würzburg
country: Germany
facility: Research Site
city: Zerbst
country: Germany
facility: Research Site
city: Zwickau
country: Germany
facility: Research Site
Study officials:
affiliation: Klinikum Fürth
name: Heinrich Worth, MD
role: PRINCIPAL_INVESTIGATOR
References: