Efficacy of Symbicort versus its monocomponents - SPRUCE 160/4.5

Study identifier:SD-039-0717

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 12 week, Randomized, Double-blind, Double-dummy, Placebo-controlled trial of Symbicort TM (160/4.5mcg) versus its Mono-products (budesonide and formoterol) in adolescents (at least 12 years of age) and adults with asthma - SPRUCE 160/4.5

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

budesonide/formoterol, budesonide, formoterol

Sex

All

Actual Enrollment

450

Study type

Interventional

Age

12 Years +

Date

Study Start Date: 01 Jul 2002
Primary Completion Date: -
Study Completion Date: 01 Jan 2004

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria