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:
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
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
Drug: Ciclesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Takeda:

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

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
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 ClinicalTrials.gov identifier: NCT00163436

  Show 66 Study Locations
Sponsors and Collaborators
Principal Investigator: Ekkehard Beck, Dr IFG-Institut für Gesundheitsförderung GmbH, Rüdersdorf, Germany
  More Information

ClinicalTrials.gov Identifier: NCT00163436     History of Changes
Other Study ID Numbers: BY9010/M1-145 
Study First Received: September 12, 2005
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Takeda:

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

ClinicalTrials.gov processed this record on April 27, 2016