Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163345
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
  Purpose

The aim of this study is to evaluate the involvement of small airways in asthma, as determined by bronchial challenges, CT-scanning, and cellular markers of inflammation. Ciclesonide will be inhaled at one dose level once daily. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (5 to 6 weeks). The study will provide further data on safety and tolerability of ciclesonide.


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: Double-Blind
Primary Purpose: Treatment
Official Title: Evaluation of Parameters of the Small Airways and Their Changes Under Treatment With Ciclesonide (320 Mcg Once Daily) Versus Placebo in Patients With Asthma

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • variables of primary interest are FVC% at PC20 MCh, SVC% at PC20 MCh
  • FVC% at PC20 AMP, SVC% at PC20 AMP
  • regional air trapping
  • bronchial and alveolar exhaled NO
  • lung function variables
  • non-cellular inflammatory markers.

Secondary Outcome Measures:
  • safety and tolerability.

Estimated Enrollment: 20
Study Start Date: September 2003
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Written informed consent
  • History of bronchial asthma
  • FEV1 more than or equal to 60% of predicted
  • Stable asthma
  • Patients who are in good health with the exception of asthma

Main Exclusion Criteria:

  • Concomitant severe diseases, diseases expected to interfere with the outcome of the study, or diseases which are contraindications for the use of ICS
  • COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
  • Use of ICS 4 weeks before entry into the baseline period
  • Pregnancy
  • Intention to become pregnant during the course of the study
  • Breast feeding
  • Lack of safe contraception
  • Use of other drugs not allowed
  • Current smokers and ex-smokers with more than or equal to 10 pack-years
  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: NCT00163345

Locations
Netherlands
Altana Pharma/Nycomed
RB Groningen, Netherlands, 9700
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: D.S. Postma, Prof. University Hospital, Groningen, The Netherlands
  More Information

No publications provided by Takeda

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00163345     History of Changes
Other Study ID Numbers: BY9010/M1-131
Study First Received: September 12, 2005
Last Updated: May 4, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Takeda:
Asthma
Ciclesonide
Small Airways

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