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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
This study has been completed.
First Received: November 14, 2005   Last Updated: March 16, 2009   History of Changes
Sponsor: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00252863
  Purpose

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.


Condition Intervention Phase
Asthma
 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
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
Drug Information available for: Theophylline Albuterol Terbutaline Terbutaline sulfate Formoterol fumarate Levalbuterol hydrochloride Albuterol sulfate Budesonide Arformoterol Formoterol Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Symbicort Arformoterol Tartrate Levalbuterol tartrate Theophylline sodium glycinate
U.S. FDA Resources

Further study details as provided by AstraZeneca:

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)

Estimated Enrollment: 1600
Study Start Date: December 2004
Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252863

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Locations
Germany
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Amberg, Germany
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Aschaffenburg, Germany
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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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Bitte Eintragen, Germany
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Bonn, Germany
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Borna, Germany
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Burg, Germany
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Chemnitz, 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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Düsseldorf, Germany
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Solingen, Germany
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Weyhe, Germany
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Trier, Germany
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Ulm, Germany
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Uttenreuth, Germany
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Wedel, Germany
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Stadthagen, Germany
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Rostock, Mecklenburg-Vorpommern, Germany
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Hannover, Niedersachsen, Germany
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Düsseldorf, Nordrhein-Westfalen, Germany
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Münster, Nordrhein-Westfalen, Germany
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Mainz, Rheinland-Pfalz, Germany
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Saarbrücken, Saarland, Germany
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Halle, Sachsen-Anhalt, Germany
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Bad Segeberg, Schleswig-Holstein, Germany
Germany, Thüringen
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Jena-Maua, Thüringen, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Heinrich Worth, MD Klinikum Fürth
  More Information

No publications provided

Study ID Numbers: D5890L00011, DESOLO
Study First Received: November 14, 2005
Last Updated: March 16, 2009
ClinicalTrials.gov Identifier: NCT00252863     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Symbicort
Albuterol
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Adrenergic Agonists
Terbutaline
 Hypersensitivity
Lung Diseases, Obstructive
Tocolytic Agents
Respiratory Tract Diseases
Therapeutic Uses
Formoterol
Fluticasone
Dermatologic Agents
Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Sympathomimetics
Budesonide
Asthma
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on November 30, 2009



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