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

Tracking Information

First Received Date ^ICMJE

November 14, 2005

Last Updated Date

March 16, 2009

Start Date ^ICMJE

December 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Time to first severe asthma exacerbation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00252863 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Number of severe asthma exacerbations
Mean use of as-needed medication
Change in 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
SAEs
Discontinuations due to AEs

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

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 Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1600

Completion Date

May 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00252863

Responsible Party

Study ID Numbers ^ICMJE

D5890L00011, DESOLO

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Heinrich Worth, MD

Klinikum Fürth

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP