DESOLO – SiT peri-launch: A comparison of Symbicort Single inhaler Therapy and conventional best practice for the treatment of persistent asthma in adults

Study identifier:D5890L00011

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

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

Sex

All

Actual Enrollment

1600

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Dec 2004
Primary Completion Date: -
Study Completion Date: 01 May 2006

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria