Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00314509
First received: April 11, 2006
Last updated: May 4, 2012
Last verified: July 2008

April 11, 2006
May 4, 2012
July 2005
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  • Time to the first experience of lack of efficacy
  • AUC (FEV1) over a 24 h dosing interval.
Same as current
Complete list of historical versions of study NCT00314509 on ClinicalTrials.gov Archive Site
  • FEV1
  • morning and evening PEF, asthma symptoms and use of rescue medication
  • proportion of patients with a clinical asthma exacerbation.
  • FEV1
  • morning and evening PEF, asthma symptoms and use of rescue medication
  • proportion of patients with a clinical asthma exacerbation
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Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)
ADVICE: A Dose Range Finding Study of Formoterol Administered Once Daily in the Evening in Combination With Ciclesonide Using the Ultrahaler™ Versus Monotherapy of Each Drug in Asthmatic Patients

The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). The study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.

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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
Drug: Ciclesonide/Formoterol Combination
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
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Main Inclusion Criteria:

  • Written informed consent
  • Good health with the exception of bronchial asthma (for at least 6 months)
  • FEV1 > 60% to < 80% of predicted (if pretreated with inhaled steroids only)
  • FEV1 > 60% to ≤ 85% of predicted (if pretreated with inhaled steroids in combination with other asthma controller)

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or long-acting beta2-agonists
  • Chronic obstructive pulmonary disease (COPD), i.e. chronic bronchitis or emphysema, and/or other relevant lung diseases causing alternating impairment in pulmonary function
  • Current smoking or cessation of smoking within the last 6 months or previous smoking with a smoking history ≥ 10 cigarette pack-years
  • Use of other drugs not allowed
  • Pregnancy or intention to become pregnant during the course of the study, breast feeding, or lack of safe contraception in women of childbearing potential
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Hungary,   South Africa
 
NCT00314509
BY9010/M1-506
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Takeda
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Principal Investigator: Eric D. Bateman, Prof. UCT Lung Institute, 7700 Mowbray, Cape Town, South Africa
Takeda
July 2008

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