AsthmaPhase 3NCT00252863

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

A Phase 3 study testing Symbicort, used twice daily (b.i.d) and as needed (prn), Budesonide Turbuhaler 200 µg and Fluticasone Discus 250 µg in people with Asthma, run by AstraZeneca at 169 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: Symbicort, used twice daily (b.i.d) and as needed (prn), Budesonide Turbuhaler 200 µg and Fluticasone Discus 250 µg
How many people: 1,600 participants
Where: 169 sitesGermany
Study dates: Dec 2004to May 2006
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Any other significant lung disease other than asthma
Any disease that might put patients at risk if they participate in the study

Trial locations and contacts

169 sites in 1 country.

City, postcode or hospital

169 sites in 1 country

Germany169 sites

Research Site
Amberg
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Aschaffenburg
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Auerbach
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Augsburg
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Backnang
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Bad Arolsen
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Bad Doberan
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Bad Lippspringe
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Bad Neuenahr
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Bad Reichenhall
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Bad Segeberg, Schleswig-Holstein
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Bad Sessendorf
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Bayreuth
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Bensheim
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Bergisch Gladbach
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Berlin, State of Berlin
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Berlin
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Bitte Eintragen
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Bochum
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Bonn
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Borna
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Brake
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Burg
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Burgwedel
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Castrop-Rauxel
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Chemnitz
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Cologne
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Coswig
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Cottbus, Brandenburg
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Cottbus
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Damme
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Darmstadt
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Deggendorf
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Dillingen
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Dinslaken
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Dortmund
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Dresden, Saxony
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Dresden
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Dülmen
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Düsseldorf, North Rhine-Westphalia
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Düsseldorf
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Eisenach
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Eisenhüttenstadt
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Emden
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Erfurt
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Erkelenz
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Eschwege
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Flensburg
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Forchheim
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Frankenthal
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Frankfurt
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Frankfurt am Main, Hesse
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Freiberg
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Freiburg im Breisgau
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Freising
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Fulda
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Fürstenwalde
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Fürth
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Gelsenkirchen
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Giessen
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Göppingen
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Gotha
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Günzburg
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Gütersloh
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Hagen
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Halle, Saxony-Anhalt
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Halle
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Hamburg, Free and Hanseatic City of Hamburg
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Hamburg
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Hamm
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Hanover, Lower Saxony
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Hanover
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Harpstedt
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Hartha
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Heidelberg
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Heilbronn
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Homburg-Saar
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Hoyerswerda
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Iserloh
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Jena-Maua, Thuringia
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Kamen
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Kamenz
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Kamp-Lintfort
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Karlsruhe
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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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Landsberg
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Leipzig
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Leonberg
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Leverkusen
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Loerrach
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Lübeck
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Ludwigsburg
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Lüneburg
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Magdeburg
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Mainaschaff
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Mainz, Rhineland-Palatinate
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Mainz
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Marburg
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Markkleeberg
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Memmingen
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Moers
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Mönchengladbach
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Mühlhausen
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München, Bavaria
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München
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Münster, North Rhine-Westphalia
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Neubrandenburg
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Neuss
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Neuwied
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Niesky
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Nordhausen
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Oberhausen
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Oranienburg
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Oschersleben
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Paderborn
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Passau
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Peine
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Pforzheim
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Pinneberg
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Potsdam
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Ratingen
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Recklinghausen
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Regensburg
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Reutlingen
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Rheine
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Rodenbach
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Rostock, Mecklenburg-Vorpommern
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Rostock
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Rottweil
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Rudolstadt
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Saalfeld
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Saarbrücken, Saarland
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Saarbrücken
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Saarlouis
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Salzgitter
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Sangerhausen
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Schleswig
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Schwabach
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Schwäbisch Gmünd
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Schwerin
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Siegen
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Simmern
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Sindelfingen
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Singen
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Solingen
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Stade
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Stadthagen
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Steinhagen
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Stuttgart, Baden-Wurttemberg
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Stuttgart
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Trier
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Ulm
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Uttenreuth
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Wardenburg
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Wedel
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Weinheim
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Weyhe
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Witten
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Worpswede
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Würzburg
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Zerbst
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Zwickau

Other trials in Germany

About this study

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

Conditions: Asthma
Being tested: 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
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Symbicort, used twice daily (b.i.d) and as needed (prn)Drug
Budesonide Turbuhaler 200 µgDrug
Fluticasone Discus 250 µgDrug
Formoterol Turbuhaler 4.5 µgDrug
Terbutaline Turbuhaler 0.5 mgDrug
Salbutamol pressurized metered dose inhaler (pMDI) 100 µgDrug
Salmeterol Discus 50 µgDrug
Budesonide/Formoterol Turbuhaler 160/4.5 µgDrug
Fluticasone/Salmeterol Discus 250/50 µgDrug
Fluticasone/Salmeterol Discus 500/50 µgDrug
Theophylline 200 mgDrug
Theophylline 300 mgDrug
Singulair 10 mgDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2004May 2006

First posted15 Nov 2005 (estimated)
Study startDec 2004
Study completionMay 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,600 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00252863
Sponsor's protocol ID: D5890L00011
Other IDs: DESOLO
Status last verified: Mar 2009
First submitted: 14 Nov 2005
Last updated: 17 Mar 2009
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00252863
Acronym / sponsor ID: D5890L00011
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,600 participants
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2004
Study completion: May 2006 (actual)
First posted: 15 Nov 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (2 listed)

Any other significant lung disease other than asthma
Any disease that might put patients at risk if they participate in the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	–
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	–

Primary outcome

Time to first severe asthma exacerbation

11 secondary outcomes

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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2009.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heinrich Worth, MD principal investigator

Klinikum Fürth

169 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first severe asthma exacerbation. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00252863.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2009.