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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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Asthma

Treatments

Drug: Terbutaline Turbuhaler 0.5 mg
Drug: Fluticasone Discus 250 µg
Drug: Salmeterol Discus 50 µg
Drug: Formoterol Turbuhaler 4.5 µg
Drug: Singulair 10 mg
Drug: Theophylline 200 mg
Drug: Fluticasone/Salmeterol Discus 500/50 µg
Drug: Budesonide Turbuhaler 200 µg
Drug: Symbicort, used twice daily (b.i.d) and as needed (prn)
Drug: Fluticasone/Salmeterol Discus 250/50 µg
Drug: Salbutamol pressurized metered dose inhaler (pMDI) 100 µg
Drug: Budesonide/Formoterol Turbuhaler 160/4.5 µg
Drug: Theophylline 300 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00252863
D5890L00011
DESOLO

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

167

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Data sourced from clinicaltrials.gov

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