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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:
ClinicalTrials.gov Identifier:
NCT00163436
First Posted: September 14, 2005
Last Update Posted: November 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
September 12, 2005
September 14, 2005
November 30, 2016
September 2005
January 2006   (Final data collection date for primary outcome measure)
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
Intervention Model: Parallel Assignment
Masking: None (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
January 2006
January 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 75 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Germany,   Hungary,   India,   Italy
 
 
NCT00163436
BY9010/M1-145
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca AstraZeneca AstraZeneca
AstraZeneca
October 2016

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