Efficacy and Safety of Ciclesonide (CIC) administered twice daily in pediatric patients with asthma.

Study identifier:EFC6695

ClinicalTrials.gov identifier:NCT00392288

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A multicenter, multi-national, randomized, double-blind, placebo-controlled, study to assess the efficacy and safety of ciclesonide metered-dose inhaler (MDI) at 80 μg BID or 40 μg BID for 12 weeks in patients aged 4 to <12 years with persistent asthma.

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

Ciclesonide, Placebo

Sex

All

Actual Enrollment

528

Study type

Interventional

Age

4 Years - 11 Years

Date

Study Start Date: 01 Sept 2006
Primary Completion Date: 01 Feb 2008
Study Completion Date: 01 Feb 2008

Study design

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

Verification:

Verified 01 Sept 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria