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A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma (6-11 y) (BY9010/M1-209)

This study has been completed.
Sponsor:
Information provided by:
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00384189
First received: October 4, 2006
Last updated: May 4, 2012
Last verified: July 2008
History of Changes
  Purpose

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 with asthma. Treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily. 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.


Condition Intervention Phase
Asthma
 Drug: Ciclesonide
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
Drug Information available for: Ciclesonide
U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • lung function. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • asthma symptoms and lung function. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1050
Study Start Date: October 2006
Study Completion Date: June 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ciclesonide 40µg
 Drug: Ciclesonide
inhaled Ciclesonide
Active Comparator: 2
Ciclesonide 80µg
 Drug: Ciclesonide
inhaled Ciclesonide
Active Comparator: 3
160µg
 Drug: Ciclesonide
inhaled Ciclesonide
Placebo Comparator: 4
Placebo
 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • History of asthma for at least 6 months
  • Ability to show optimal use of MDI, including inhalation technique
  • Lung function and reversibility within specified limits

Main Exclusion Criteria:

  • Concomitant severe diseases
  • Diseases which are contraindications for the use of inhaled steroids
  • Two or more inpatient hospitalizations for asthma within the last year
  • Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
  • Use of systemic steroids within the last 30 days prior to inclusion (depot steroids 6 weeks)
  • Beginning of or change in immunotherapy within the last 6 months prior to inclusion
  • Inability to follow the procedures of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00384189

  Show 123 Study Locations
Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
Principal Investigator: Søren Pedersen, Prof. Odense University Hospital, Kolding, Denmark
  More Information

No publications provided by Takeda Global Research & Development Center, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nycomed GmbH, Nycomed
ClinicalTrials.gov Identifier: NCT00384189     History of Changes
Other Study ID Numbers: BY9010/M1-209
Study First Received: October 4, 2006
Last Updated: May 4, 2012
Health Authority: South Africa: Medicines Control Council

Keywords provided by Takeda Global Research & Development Center, Inc.:
Asthma
Ciclesonide
children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Ciclesonide
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013