CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,080 enrolled
Drug / intervention
Ciclesonide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00384189
NCT00384189Phase 3Completed
CompareCT.gov

A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma

AstraZeneca·interventional·Posted Oct 5, 2006·Updated Feb 1, 2017

In Brief

A Phase 3 clinical trial evaluating Ciclesonide, Placebo, and 1 other intervention for Asthma. Completed, enrolled 1,080 participants across 122 sites in 9 countries.

Detailed Summary

The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily in the evening. The study consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study provides further data on safety and tolerability of ciclesonide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBulgaria, Germany, Hungary, Poland, Romania, Russia, South Africa, Spain, Ukraine
CollaboratorsNycomed GmbH

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 5, 2006
Enrollment StartSep 1, 2006
Primary CompletionAug 1, 2007
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.7 years ago

Interventions

Ciclesonidedrug

inhaled Ciclesonide

Placebodrug

Ciclesonide placebo-matching inhaler

Salbutamoldrug

Salbutamol inhalation powder