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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma Ciclesonide Small Airways

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ciclesonide

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Altana Pharma/Nycomed

RB Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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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. doi: 10.1183/09031936.00082407. Epub 2008 Feb 20.

Reference Type DERIVED

PMID: 18287130 (View on PubMed)

Other Identifiers

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BY9010/M1-131

Identifier Type: -

Identifier Source: org_study_id