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Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)

This study has been completed.
Sponsor:
Information provided by:
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00163423
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, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate 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 (24 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 Once Daily in the Evening) and Fluticasone Propionate (100 Mcg Twice Daily) in Patients With Mild to Moderate Asthma

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
  • time to the first asthma exacerbation.

Secondary Outcome Measures:
  • FVC
  • asthma symptom score
  • use of rescue medication
  • AQLQ(S) and EQ-5D
  • percentage of days on which patients perceived asthma control
  • percentage of nocturnal awakening-free days
  • percentage of rescue medication-free days
  • percentage of asthma symptom-free days
  • physical examination
  • vital signs
  • standard laboratory work-up
  • adverse events
  • number of patients with local oropharyngeal adverse events.

Estimated Enrollment: 480
Study Start Date: November 2004
  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Outpatients
  • Written informed consent
  • History of bronchial asthma for at least 6 months
  • Good health with the exception of asthma
  • Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
  • FEV1 80 - 105% of predicted

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
  • Current smoking with more than 10 pack-years
  • Previous smoking with more than 10 pack-years
  • Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
  • 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: NCT00163423

  Show 51 Study Locations
Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
Principal Investigator: Ronald Dahl, Prof. Aarhus University Hospital, Aarhus, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163423     History of Changes
Other Study ID Numbers: BY9010/M1-142
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
Fluticasone propionate

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 22, 2013