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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: 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

• Study Type: Interventional
• Enrollment: 1600
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Amberg, Germany
    • Research Site
  • Aschaffenburg, Germany
    • Research Site
  • Auerbach, Germany
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  • Augsburg, Germany
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  • Backnang, Germany
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  • Bad Arolsen, Germany
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  • Bad Doberan, Germany
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  • Bad Lippspringe, Germany
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  • Bad Neuenahr, Germany
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  • Bad Reichenhall, Germany
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  • Bad Sessendorf, Germany
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  • Bayreuth, Germany
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  • Bensheim, Germany
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  • Bergisch Gladbach, Germany
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  • Berlin, Germany
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  • Bitte Eintragen, Germany
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  • Bochum, Germany
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  • Bonn, Germany
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  • Borna, Germany
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  • Brake, Germany
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  • Burg, Germany
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  • Burgwedel, Germany
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  • Castrop-Rauxel, Germany
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  • Chemnitz, Germany
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  • Coswig, Germany
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  • Cottbus, Germany
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  • Damme, Germany
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  • Darmstadt, Germany
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  • Deggendorf, Germany
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  • Dillingen, Germany
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  • Dinslaken, Germany
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  • Dortmund, Germany
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  • Dresden, Germany
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  • Dülmen, Germany
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  • Düsseldorf, Germany
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  • Eisenach, Germany
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  • Eisenhüttenstadt, Germany
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  • Emden, Germany
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  • Erfurt, Germany
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  • Erkelenz, Germany
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  • Eschwege, Germany
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  • Flensburg, Germany
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  • Forchheim, Germany
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  • Frankenthal, Germany
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  • Frankfurt, Germany
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  • Freiberg, Germany
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  • Freiburg, Germany
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  • Freising, Germany
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  • Fulda, Germany
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  • Fürstenwalde, Germany
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  • Fürth, Germany
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  • Gelsenkirchen, Germany
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  • Gießen, Germany
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  • Gotha, Germany
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  • Göppingen, Germany
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  • Günzburg, Germany
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  • Gütersloh, Germany
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  • Hagen, Germany
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  • Halle, Germany
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  • Hamburg, Germany
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  • Hamm, Germany
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  • Hannover, Germany
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  • Harpstedt, Germany
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  • Hartha, Germany
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  • Heidelberg, Germany
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  • Heilbronn, Germany
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  • Homburg-Saar, Germany
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  • Hoyerswerda, Germany
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  • Iserloh, Germany
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  • Kamen, Germany
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  • Kamenz, Germany
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  • Kamp-Lintfort, Germany
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  • Karlsruhe, Germany
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  • Kassel, Germany
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  • Kaufbeuren, Germany
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  • Kempten, Germany
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  • Kiel, Germany
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  • Kitzingen, Germany
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  • Koblenz, Germany
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  • Krefeld, Germany
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  • Kronach, Germany
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  • Köln, Germany
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  • Landsberg, Germany
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  • Leipzig, Germany
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  • Leonberg, Germany
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  • Leverkusen, Germany
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  • Ludwigsburg, Germany
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  • Lörrach, Germany
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  • Lübeck, Germany
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  • Lüneburg, Germany
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  • Magdeburg, Germany
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  • Mainaschaff, Germany
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  • Mainz, Germany
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  • Marburg, Germany
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  • Markkleeberg, Germany
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  • Memmingen, Germany
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  • Moers, Germany
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  • Mönchengladbach, Germany
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  • Mühlhausen, Germany
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  • München, Germany
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  • Neubrandenburg, Germany
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  • Neuss, Germany
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  • Neuwied, Germany
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  • Niesky, Germany
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  • Nordhausen, Germany
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  • Oberhausen, Germany
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  • Oranienburg, Germany
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  • Oschersleben, Germany
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  • Paderborn, Germany
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  • Passau, Germany
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  • Peine, Germany
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  • Pforzheim, Germany
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  • Pinneberg, Germany
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  • Potsdam, Germany
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  • Ratingen, Germany
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  • Recklinghausen, Germany
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  • Regensburg, Germany
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  • Reutlingen, Germany
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  • Rheine, Germany
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  • Rodenbach, Germany
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  • Rostock, Germany
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  • Rottweil, Germany
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  • Rudolstadt, Germany
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  • Saalfeld, Germany
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  • Saarbrücken, Germany
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  • Saarlouis, Germany
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  • Salzgitter, Germany
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  • Sangerhausen, Germany
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  • Schleswig, Germany
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  • Schwabach, Germany
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  • Schwerin, Germany
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  • Schwäbisch Gmünd, Germany
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  • Siegen, Germany
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  • Simmern, Germany
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  • Sindelfingen, Germany
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  • Singen, Germany
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  • Solingen, Germany
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  • Stade, Germany
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  • Stadthagen, Germany
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  • Steinhagen, Germany
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  • Stuttgart, Germany
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  • Trier, Germany
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  • Ulm, Germany
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  • Uttenreuth, Germany
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  • Wardenburg, Germany
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  • Wedel, Germany
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  • Weinheim, Germany
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  • Weyhe, Germany
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  • Witten, Germany
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  • Worpswede, Germany
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  • Würzburg, Germany
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  • Zerbst, Germany
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  • Zwickau, Germany
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  • Baden-Württemberg
    • Stuttgart, Baden-Württemberg, Germany
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  • Bayern
    • München, Bayern, Germany
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  • Brandenburg
    • Cottbus, Brandenburg, Germany
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  • Hessen
    • Frankfurt, Hessen, Germany
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  • Mecklenburg-Vorpommern
    • Rostock, Mecklenburg-Vorpommern, Germany
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  • Niedersachsen
    • Hannover, Niedersachsen, Germany
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  • Nordrhein-Westfalen
    • Düsseldorf, Nordrhein-Westfalen, Germany
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    • Münster, Nordrhein-Westfalen, Germany
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  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany
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  • Saarland
    • Saarbrücken, Saarland, Germany
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  • Sachsen
    • Dresden, Sachsen, Germany
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  • Sachsen-Anhalt
    • Halle, Sachsen-Anhalt, Germany
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  • Schleswig-Holstein
    • Bad Segeberg, Schleswig-Holstein, Germany
      • Research Site
  • Thüringen
    • Jena-Maua, Thüringen, Germany
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to first severe asthma exacerbation

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Heinrich Worth, MD, Klinikum Fürth

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Study Completion (Actual): May 1, 2006

Study Registration Dates

• First Submitted: November 14, 2005
• First Submitted That Met QC Criteria: November 14, 2005
• First Posted (Estimate): November 15, 2005

Study Record Updates

• Last Update Posted (Estimate): March 17, 2009
• Last Update Submitted That Met QC Criteria: March 16, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Purinergic Antagonists; Purinergic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Reproductive Control Agents; Anti-Allergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Sympathomimetics; Budesonide; Montelukast; Theophylline; Fluticasone; Xhance; Albuterol; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Terbutaline; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: D5890L00011; DESOLO