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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.
Study NCT00163423   Information provided by ALTANA Pharma
First Received: September 12, 2005   Last Updated: July 16, 2008   History of Changes

September 12, 2005
July 16, 2008
November 2004
 
  • FEV1
  • time to the first asthma exacerbation.
Same as current
Complete list of historical versions of study NCT00163423 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
 
Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)
Comparison of Ciclesonide (80 Mcg Once Daily in the Evening) and Fluticasone Propionate (100 Mcg Twice Daily) in Patients With Mild to Moderate Asthma

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.

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Asthma
Drug: Ciclesonide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
480
 
 

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
Both
12 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Canada,   Germany,   Poland,   South Africa
 
NCT00163423
 
BY9010/M1-142
ALTANA Pharma
 
Principal Investigator: Ronald Dahl, Prof. Aarhus University Hospital, Aarhus, Denmark
ALTANA Pharma
July 2008

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