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

This study has been completed.

First Received: September 12, 2005 Last Updated: July 16, 2008 History of Changes

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163345

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Asthma

Drug Information available for: Ciclesonide

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163345

Locations

Netherlands
Altana Pharma/Nycomed
RB Groningen, Netherlands, 9700

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

D.S. Postma, Prof.

University Hospital, Groningen, The Netherlands

More Information

No publications provided by ALTANA Pharma

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Cohen J, Douma WR, ten Hacken NH, Vonk JM, Oudkerk M, Postma DS. Ciclesonide improves measures of small airway involvement in asthma. Eur Respir J. 2008 Jun;31(6):1213-20. Epub 2008 Feb 20.

Study ID Numbers:	BY9010/M1-131
Study First Received:	September 12, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00163345 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by ALTANA Pharma:

Asthma
Ciclesonide
Small Airways

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Ciclesonide

Lung Diseases
Hypersensitivity, Immediate
Asthma
Anti-Allergic Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Bronchial Diseases
Immune System Diseases
Ciclesonide
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 11, 2009