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Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
This study has been completed.
Study NCT00163319   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
 
number of patients with candidiasis of the oropharynx or hoarseness.
Same as current
Complete list of historical versions of study NCT00163319 on ClinicalTrials.gov Archive Site
  • inhaled Corticosteroids Questionnaire (ICQ)
  • proportion of cases of candidiasis of the oropharynx or
  • hoarseness at each visit Secondary variables
  • FEV1, FVC, PEF from spirometry
  • morning and evening PEF from diaries
  • diurnal PEF fluctuation
  • onset of treatment effect
  • percent days on which patient perceived asthma control
  • percent of nocturnal awakening-free days
  • percent of rescue medication free days
  • percent symptom free days
  • asthma symptom score
  • use of rescue medication
  • time to first asthma exacerbation
  • number of patients with an asthma exacerbation
  • AQLQ
  • number of patients with candidiasis of the oropharynx or hoarseness by severity
  • physical examination, ECG
  • vital sings
  • adverse events
  • standard laboratory work-up
  • morning serum cortisol
  • skin bruising.
Same as current
 
Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
Comparison of Inhaled Ciclesonide (640 Mcg/Day) and Fluticasone Propionate (1000 Mcg/Day) in Patients With Moderate and Severe Persistent Asthma

The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 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
500
 
 

Main Inclusion Criteria:

  • Written informed consent
  • History of bronchial asthma for at least 6 months
  • Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination
  • FEV1 ≥ 80% of predicted

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs
  • COPD
  • Smoking with ≥10 pack-years
  • Pregnancy
  • Intention to become pregnant during the course of the study
  • Breast feeding
  • Lack of safe contraception
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Italy,   Netherlands,   Spain,   Switzerland,   United Kingdom
 
NCT00163319
 
BY9010/IT-101
ALTANA Pharma
 
Principal Investigator: Daniel Dusser, MD, PhD Hospital COCHIN, Paris, France
ALTANA Pharma
July 2008

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