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A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma

NCT00384189 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1080

Last updated 2017-02-01

Study results available
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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.

Conditions

Interventions

DRUG

Ciclesonide

inhaled Ciclesonide

DRUG

Placebo

Ciclesonide placebo-matching inhaler

DRUG

Salbutamol

Salbutamol inhalation powder

Sponsors & Collaborators

  • Nycomed GmbH

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • AstraZeneca AstraZeneca · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2007-08-31
Completion
2008-08-31

Countries

  • Bulgaria
  • Germany
  • Hungary
  • Poland
  • Romania
  • Russia
  • South Africa
  • Spain
  • Ukraine

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00384189 on ClinicalTrials.gov