Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163436
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008

September 12, 2005
May 4, 2012
September 2005
Not Provided
FEV1.
Same as current
Complete list of historical versions of study NCT00163436 on ClinicalTrials.gov Archive Site
  • FVC
  • morning and evening PEF from diaries
  • asthma symptom score
  • use of rescue medication
  • number of patients with an asthma exacerbation
  • time to the first asthma exacerbation
  • percentage of days on which patient perceived asthma control
  • percentage of nocturnal awakening-free days
  • percentage of rescue medication-free days
  • percentage of asthma symptom-free days
  • adverse events
  • physical examination
  • vital signs
  • standard laboratory work-up
  • 8 am serum cortisol.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)
Comparison of the Efficacy and Safety of 160 Mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types in Patients With Asthma

The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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
450
Not Provided
Not Provided

Main Inclusion Criteria:

  • Written informed consent
  • History of persistent bronchial asthma for at least 6 months
  • Good health with the exception of asthma

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • Smoking history with ≥10 cigarette pack years
  • Pregnancy
  • Intention to become pregnant
  • Breast feeding
  • Lack of safe contraception
  • Previous enrolment into the current study
Both
12 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Canada,   Italy,   Germany,   Hungary,   India
 
NCT00163436
BY9010/M1-145
Not Provided
Not Provided
Takeda
Not Provided
Principal Investigator: Ekkehard Beck, Dr IFG-Institut für Gesundheitsförderung GmbH, Rüdersdorf, Germany
Takeda
July 2008

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