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:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163436
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
  Purpose

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
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
  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Takeda
Investigators
Principal Investigator: Ekkehard Beck, Dr IFG-Institut für Gesundheitsförderung GmbH, Rüdersdorf, Germany
  More Information

No publications provided

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:
Asthma
Ciclesonide

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

ClinicalTrials.gov processed this record on September 16, 2014