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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
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: Ciclesonide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

Primary Outcome Measures:
  • FEV1 absolute values
  • PD20FEV1 from methacholine challenge.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 750
Study Start Date: October 2004
  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163462

  Show 57 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

ClinicalTrials.gov Identifier: NCT00163462     History of Changes
Other Study ID Numbers: BY9010/M1-206
Study First Received: September 12, 2005
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Takeda Global Research & Development Center, Inc.:
Asthma
Ciclesonide
Child
Fluticasone propionate
Pediatric

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Ciclesonide
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013