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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: September 12, 2005
Last updated: December 7, 2016
Last verified: December 2016
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
Intervention Model: Parallel Assignment
Masking: Double
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 AstraZeneca:

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
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00163345

Altana Pharma/Nycomed
RB Groningen, Netherlands, 9700
Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00163345     History of Changes
Other Study ID Numbers: BY9010/M1-131
Study First Received: September 12, 2005
Last Updated: December 7, 2016

Keywords provided by AstraZeneca:
Small Airways

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 20, 2017