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”

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 Type: Interventional

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

Study Primary Completion Date: May 2006

Intervention(s) in this Clinical Trial

• 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

Primary Measures

• Time to first severe asthma exacerbation

Secondary 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)

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Heinrich Worth, MD Principal Investigator Klinikum Fürth  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00252863

Study ID Number: D5890L00011

ClinicalTrials.gov Identifier: NCT00252863

Health Authority: Germany: Federal Institute for Drugs and Medical Devices