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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00252863

Enrollment

1600

Registered

2005-11-15

Start date

2004-12-31

Completion date

2006-05-31

Last updated

2009-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DRUGSymbicort, used twice daily (b.i.d) and as needed (prn)

DRUGBudesonide Turbuhaler 200 µg

DRUGFluticasone Discus 250 µg

DRUGFormoterol Turbuhaler 4.5 µg

DRUGTerbutaline Turbuhaler 0.5 mg

DRUGSalbutamol pressurized metered dose inhaler (pMDI) 100 µg

DRUGSalmeterol Discus 50 µg

DRUGBudesonide/Formoterol Turbuhaler 160/4.5 µg

DRUGFluticasone/Salmeterol Discus 250/50 µg

DRUGFluticasone/Salmeterol Discus 500/50 µg

DRUGTheophylline 200 mg

DRUGTheophylline 300 mg

DRUGSingulair 10 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to first severe asthma exacerbation	—

Secondary

Measure	Time frame
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)	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026