Long-term safety of Symbicort in asthmatic children - SAPLING

Study identifier:SD-039-0719

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A six month, Randomized, Open-Label, Safety Study of Symbicort (160/4.5mcg) compared to Pulmicort Turbuhaler in asthmatic children aged six to eleven years - SAPLING

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

Study drug

budesonide/formoterol (Symbicort), budesonide (Pulmicort)

Sex

All

Actual Enrollment

175

Study type

Interventional

Age

6 Years - 11 Years

Date

Study Start Date: 01 Jul 2002

Primary Completion Date: -

Study Completion Date: 01 Oct 2003

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
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=1109&filename=CSR-SD-039-0719.pdf
Download
CSR-SD-039-0719.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