Back to resultsDESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
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
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Outcomes
Primary Outcome Measures
Time to first severe asthma exacerbation
Secondary Outcome Measures
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00252863
Brief Title
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
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Symbicort, used twice daily (b.i.d) and as needed (prn)
Intervention Type
Drug
Intervention Name(s)
Budesonide Turbuhaler 200 µg
Intervention Type
Drug
Intervention Name(s)
Fluticasone Discus 250 µg
Intervention Type
Drug
Intervention Name(s)
Formoterol Turbuhaler 4.5 µg
Intervention Type
Drug
Intervention Name(s)
Terbutaline Turbuhaler 0.5 mg
Intervention Type
Drug
Intervention Name(s)
Salbutamol pressurized metered dose inhaler (pMDI) 100 µg
Intervention Type
Drug
Intervention Name(s)
Salmeterol Discus 50 µg
Intervention Type
Drug
Intervention Name(s)
Budesonide/Formoterol Turbuhaler 160/4.5 µg
Intervention Type
Drug
Intervention Name(s)
Fluticasone/Salmeterol Discus 250/50 µg
Intervention Type
Drug
Intervention Name(s)
Fluticasone/Salmeterol Discus 500/50 µg
Intervention Type
Drug
Intervention Name(s)
Theophylline 200 mg
Intervention Type
Drug
Intervention Name(s)
Theophylline 300 mg
Intervention Type
Drug
Intervention Name(s)
Singulair 10 mg
Primary Outcome Measure Information:
Title
Time to first severe asthma exacerbation
Secondary Outcome Measure Information:
Title
Number of severe asthma exacerbations
Title
Mean use of as-needed medication
Title
Change in forced expiratory volume in 1 second (FEV1) from the end of run-in to the end of the study period
Title
Prescribed asthma medication during the treatment period
Title
Asthma Control Questionnaire (ACQ)
Title
Patient's satisfaction with the treatment question
Title
Health care contacts
Title
Asthma medication
Title
Time lost from paid and unpaid work
Title
Serious adverse events (SAEs)
Title
Discontinuations due to adverse events (AEs)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinrich Worth, MD
Organizational Affiliation
Klinikum Fürth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Stuttgart
State/Province
Baden-Württemberg
Country
Germany
Facility Name
Research Site
City
München
State/Province
Bayern
Country
Germany
Facility Name
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City
Cottbus
State/Province
Brandenburg
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Germany
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City
Frankfurt
State/Province
Hessen
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Germany
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City
Rostock
State/Province
Mecklenburg-Vorpommern
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Germany
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City
Hannover
State/Province
Niedersachsen
Country
Germany
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City
Düsseldorf
State/Province
Nordrhein-Westfalen
Country
Germany
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Research Site
City
Münster
State/Province
Nordrhein-Westfalen
Country
Germany
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City
Mainz
State/Province
Rheinland-Pfalz
Country
Germany
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Saarbrücken
State/Province
Saarland
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Germany
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Halle
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Sachsen-Anhalt
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Germany
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Dresden
State/Province
Sachsen
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Germany
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City
Bad Segeberg
State/Province
Schleswig-Holstein
Country
Germany
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City
Jena-Maua
State/Province
Thüringen
Country
Germany
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Amberg
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Germany
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Aschaffenburg
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Germany
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Auerbach
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Germany
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Augsburg
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Germany
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Backnang
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Germany
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Bad Arolsen
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Germany
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Bad Doberan
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Germany
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Bad Lippspringe
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Germany
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Bad Neuenahr
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Germany
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Bad Reichenhall
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Germany
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Bad Sessendorf
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Germany
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Bayreuth
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Germany
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Bensheim
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Germany
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Bergisch Gladbach
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Germany
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Berlin
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Germany
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Bitte Eintragen
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Germany
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Bochum
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Germany
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Bonn
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Germany
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Borna
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Germany
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Brake
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Germany
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Burgwedel
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Germany
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Burg
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Germany
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Castrop-Rauxel
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Germany
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Chemnitz
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Germany
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Coswig
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Germany
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Cottbus
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Germany
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Damme
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Germany
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Darmstadt
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Germany
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Deggendorf
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Germany
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Dillingen
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Germany
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Dinslaken
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Germany
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Dortmund
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Germany
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Dresden
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Germany
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Dülmen
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Germany
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Düsseldorf
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Germany
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Eisenach
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Germany
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Eisenhüttenstadt
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Germany
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Emden
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Germany
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Erfurt
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Germany
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Erkelenz
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Germany
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Eschwege
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Germany
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Flensburg
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Germany
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Forchheim
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Frankenthal
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Frankfurt
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Freiberg
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Freiburg
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Freising
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Fulda
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Germany
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Fürstenwalde
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Germany
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Fürth
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Germany
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Gelsenkirchen
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Germany
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Gießen
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Germany
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Gotha
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Germany
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Göppingen
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Germany
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Günzburg
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Gütersloh
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Hagen
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Halle
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Hamburg
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Hamm
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Hannover
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Harpstedt
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Hartha
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Germany
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Heidelberg
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Germany
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Heilbronn
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Germany
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Homburg-Saar
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Germany
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Hoyerswerda
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Germany
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Iserloh
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Kamenz
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Kamen
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Germany
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Karlsruhe
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Germany
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Kassel
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Kaufbeuren
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Kempten
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Kiel
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Kitzingen
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Koblenz
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Krefeld
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Kronach
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Köln
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Landsberg
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Germany
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Leipzig
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Germany
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Leonberg
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Germany
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Leverkusen
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Ludwigsburg
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Lörrach
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Germany
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Lübeck
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Germany
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Lüneburg
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Germany
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Magdeburg
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Germany
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Mainaschaff
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Germany
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Mainz
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Germany
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Marburg
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Germany
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Markkleeberg
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Germany
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Memmingen
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Germany
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Moers
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Germany
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Mönchengladbach
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Germany
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Mühlhausen
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Germany
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München
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Germany
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Neubrandenburg
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Germany
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Neuss
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Germany
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Neuwied
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Germany
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Niesky
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Germany
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Nordhausen
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Germany
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Oberhausen
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Germany
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Oranienburg
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Germany
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Oschersleben
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Germany
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Paderborn
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Germany
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Passau
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Germany
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Peine
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Germany
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Pforzheim
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Germany
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Pinneberg
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Germany
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Potsdam
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Germany
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Ratingen
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Germany
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Recklinghausen
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Germany
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Regensburg
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Germany
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Reutlingen
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Germany
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Rheine
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Germany
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Rodenbach
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Germany
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Rostock
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Germany
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Rottweil
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Germany
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Rudolstadt
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Germany
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Saalfeld
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Germany
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Saarbrücken
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Germany
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Saarlouis
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Germany
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Salzgitter
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Germany
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Sangerhausen
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Germany
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Schleswig
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Germany
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Schwabach
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Germany
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Schwerin
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Germany
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Schwäbisch Gmünd
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Germany
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Siegen
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Germany
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Simmern
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Germany
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Sindelfingen
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Germany
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Singen
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Germany
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Solingen
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Germany
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Stade
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Germany
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Stadthagen
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Germany
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Steinhagen
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Germany
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Stuttgart
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Germany
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Trier
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Germany
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Ulm
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Germany
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Uttenreuth
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Germany
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Wardenburg
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Germany
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Wedel
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Germany
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Weinheim
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Germany
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Weyhe
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Germany
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Witten
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Germany
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Worpswede
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Germany
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Würzburg
Country
Germany
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Zerbst
Country
Germany
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City
Zwickau
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults
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