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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00163410
First received: September 12, 2005
Last updated: December 1, 2016
Last verified: December 2016

September 12, 2005
December 1, 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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
Drug: Ciclesonide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
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
Both
4 Years to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00163410
BY9010/M1-205
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca AstraZeneca AstraZeneca
AstraZeneca
December 2016

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