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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: 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)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Heinrich Worth, MD, Principal Investigator, Affiliation: Klinikum Fürth

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.

Clinical Details

Official title: A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 g, 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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to first severe asthma exacerbation

Secondary outcome:

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)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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, Burgwedel, Germany

Research Site, Burg, Germany

Research Site, Castrop-Rauxel, Germany

Research Site, Chemnitz, 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, 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, Hannover, 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, Kamenz, Germany

Research Site, Kamen, Germany

Research Site, Kamp-Lintfort, Germany

Research Site, Karlsruhe, Germany

Research Site, Kassel, Germany

Research Site, Kaufbeuren, Germany

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Research Site, Landsberg, Germany

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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

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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, Schwerin, Germany

Research Site, Schwäbisch Gmünd, 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

Research Site, Stuttgart, Baden-Württemberg, Germany

Research Site, München, Bayern, Germany

Research Site, Cottbus, Brandenburg, Germany

Research Site, Frankfurt, Hessen, Germany

Research Site, Rostock, Mecklenburg-Vorpommern, Germany

Research Site, Hannover, Niedersachsen, Germany

Research Site, Düsseldorf, Nordrhein-Westfalen, Germany

Research Site, Münster, Nordrhein-Westfalen, Germany

Research Site, Mainz, Rheinland-Pfalz, Germany

Research Site, Saarbrücken, Saarland, Germany

Research Site, Dresden, Sachsen, Germany

Research Site, Halle, Sachsen-Anhalt, Germany

Research Site, Bad Segeberg, Schleswig-Holstein, Germany

Research Site, Jena-Maua, Thüringen, Germany

Additional Information

Starting date: December 2004
Last updated: March 16, 2009

Page last updated: August 23, 2015

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