Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00163410
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):

September 12, 2005
September 14, 2005
December 2, 2016
April 2003
December 2004   (Final data collection date for primary outcome measure)
FEV1 absolute values.
Same as current
Complete list of historical versions of study NCT00163410 on Archive Site
  • FEV1 as % of predicted
  • PEF from spirometry
  • diary based morning and evening PEF
  • diary based symptom score
  • diary based salbutamol MDI use
  • diurnal PEF fluctuation
  • drop-out rate due to asthma exacerbations
  • time until asthma exacerbation
  • number of symptom free- and rescue medication free days
  • number of days with asthma control
  • physical examination
  • vital signs
  • laboratory work-up
  • adverse events.
Same as current
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Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)
A Comparative Study of Inhaled Ciclesonide 200 mcg/Day vs Fluticasone Propionate 200 mcg/Day in Children With Asthma
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Drug: Ciclesonide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2004
December 2004   (Final data collection date for primary outcome measure)

Main Inclusion Criteria:

  • History of persistent bronchial asthma for at least 6 months
  • FEV1 50-90% of predicted

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
  • Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
  • History of life-threatening asthma
  • Premature birth
  • Current smoking
  • Smoking history with either equal or more than 10 pack-years
  • Pregnancy
  • Intention to become pregnant during the course of the study
  • Breast feeding
  • Lack of safe contraception
Sexes Eligible for Study: All
4 Years to 15 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
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Study Director: AstraZeneca AstraZeneca AstraZeneca
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP