Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252863
First received: November 14, 2005
Last updated: March 16, 2009
Last verified: March 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252863

  Show 167 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Heinrich Worth, MD Klinikum Fürth
  More Information

No publications provided

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Albuterol
Budesonide
Fluticasone
Fluticasone, salmeterol drug combination
Formoterol
Salmeterol
Symbicort
Theophylline
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Dermatologic Agents
Enzyme Inhibitors
Glucocorticoids

ClinicalTrials.gov processed this record on November 25, 2014