Efficacy and safety of Symbicort (budesonide/formoterol 80/4.5 mcg, 2 inhal. b.i.d.) compared to Pulmicort (budesonide 100 mcg, 2 inhal. b.i.d.) and Pulmicort (budesonide 100 mcg, 2 inhal. b.i.d.) plus Oxis (formoterol 4.5 mcg, 2 inhal. b.i.d.) all delivered via Turbuhaler in steroid using asthmatic children. A double-blind, double-dummy, randomised, parallel-group, phase III, multicentre 12-week study.

Study identifier:SD-039-0688

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Efficacy and safety of Symbicort (budesonide/formoterol 80/4.5 mcg, 2 inhal. b.i.d.) compared to Pulmicort (budesonide 100 mcg, 2 inhal. b.i.d.) and Pulmicort (budesonide 100 mcg, 2 inhal. b.i.d.) plus Oxis (formoterol 4.5 mcg, 2 inhal. b.i.d.) all delivered via Turbuhaler in steroid using asthmatic children. A double-blind, double-dummy, randomised, parallel-group, phase III, multicentre 12-week study.

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

-

Study drug

-

Sex

-

Actual Enrollment

-

Study type

Interventional

Age

-

Date

Study Start Date: 01 Mar 2002
Primary Completion Date: -
Study Completion Date: -

Study design

Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Nov 2013 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria