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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00252863
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : March 17, 2009
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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.

Condition or disease Intervention/treatment 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 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2004
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. Time to first severe asthma exacerbation

Secondary Outcome Measures :
  1. Number of severe asthma exacerbations
  2. Mean use of as-needed medication
  3. Change in forced expiratory volume in 1 second (FEV1) from the end of run-in to the end of the study period
  4. Prescribed asthma medication during the treatment period
  5. Asthma Control Questionnaire (ACQ)
  6. Patient's satisfaction with the treatment question
  7. Health care contacts
  8. Asthma medication
  9. Time lost from paid and unpaid work
  10. Serious adverse events (SAEs)
  11. Discontinuations due to adverse events (AEs)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00252863

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Sponsors and Collaborators
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Principal Investigator: Heinrich Worth, MD Klinikum Fürth

Layout table for additonal information Identifier: NCT00252863     History of Changes
Other Study ID Numbers: D5890L00011
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: March 17, 2009
Last Verified: March 2009
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists