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

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. Identifier: NCT00163436
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : November 30, 2016
Information provided by (Responsible Party):

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Asthma Drug: Ciclesonide Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Ciclesonide

Primary Outcome Measures :
  1. FEV1.

Secondary Outcome Measures :
  1. FVC
  2. morning and evening PEF from diaries
  3. asthma symptom score
  4. use of rescue medication
  5. number of patients with an asthma exacerbation
  6. time to the first asthma exacerbation
  7. percentage of days on which patient perceived asthma control
  8. percentage of nocturnal awakening-free days
  9. percentage of rescue medication-free days
  10. percentage of asthma symptom-free days
  11. adverse events
  12. physical examination
  13. vital signs
  14. standard laboratory work-up
  15. 8 am serum cortisol.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00163436

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Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00163436     History of Changes
Other Study ID Numbers: BY9010/M1-145
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: October 2016

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents