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Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)

This study has been completed.
Sponsor:
Information provided by:
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00163462
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
History of Changes

September 12, 2005
May 4, 2012
October 2004
Not Provided
  • FEV1 absolute values
  • PD20FEV1 from methacholine challenge.
Same as current
Complete list of historical versions of study NCT00163462 on ClinicalTrials.gov Archive Site
  • FEV1 as % of predicted
  • PEF from spirometry
  • morning and evening PEF from diary
  • asthma symptom score from diary
  • salbutamol MDI use from diary
  • diurnal PEF fluctuation from diary
  • dropout rate due to asthma exacerbations and time to the first asthma exacerbation
  • percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control
  • onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication
  • interview administered PAQLQ(S), self-administered PACQLQ
  • physical examination and vital signs
  • laboratory investigation
  • AEs
  • HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples.
Same as current
Not Provided
Not Provided
 
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)
Comparison of Ciclesonide (80 Mcg or 160 Mcg Once Daily in the Evening) and Fluticasone Propionate (100 Mcg Twice Daily in the Morning and Evening) in Pediatric Asthma Patients

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 once daily, using one of the two dose levels; 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
750
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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
6 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Germany,   Hungary,   Poland,   Portugal,   South Africa
 
NCT00163462
BY9010/M1-206
Not Provided
Not Provided
Takeda Global Research & Development Center, Inc.
Not Provided
Principal Investigator: Søren Pedersen, Prof. Odense University Hospital, Kolding, Denmark
Takeda Global Research & Development Center, Inc.
July 2008

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