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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.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: September 12, 2005
Last updated: November 29, 2016
Last verified: October 2016
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 Intervention Phase
Asthma Drug: Ciclesonide Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • FEV1.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 450
Study Start Date: September 2005
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00163436

  Show 66 Study Locations
Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00163436     History of Changes
Other Study ID Numbers: BY9010/M1-145
Study First Received: September 12, 2005
Last Updated: November 29, 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 processed this record on September 19, 2017