Efficacy of Symbicort pMDI administered once daily in children and adolescents during 12 weeks - SPROUT

Study identifier:SD-039-0725

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, Active-Controlled study of SYMBICORT pMDI Administered Once Daily in children and adolescents 6 to 15 years of age with asthma - SPROUT

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

Study drug

budesonide/formoterol (Symbicort), budesonide

Sex

All

Actual Enrollment

540

Study type

Interventional

Age

6 Years - 15 Years

Date

Study Start Date: 01 Apr 2003

Primary Completion Date: -

Study Completion Date: 01 Aug 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

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: 1 budesonide/formoterol	-
Active Comparator: 2 budesonide	-

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1110&filename=CSR-SD-039-0725.pdf
Download
CSR-SD-039-0725.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

null AstraZeneca Clinical Study Information

800-236-9933

[email protected]

Investigators

Principal Investigator

Catherine Bonuccelli

AstraZeneca