Effect of Inhaled Ciclesonide in Adult Patients With Asthma (BY9010/M1-125)

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

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2002-06-30

Brief Summary

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Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma. In this study the effect of ciclesonide on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and induced sputum inflammatory biomarkers will be evaluated.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma Ciclesonide Airway hyperresponsiveness Sputum Nitric oxide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Ciclesonide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Out-patients
* Written informed consent
* History of atopic disease
* History of perennial bronchial asthma for at least 6 months as defined by ATS criteria
* Current use of only inhaled short acting beta-2-agonist as required (for at least 4 weeks prior to baseline period B0)
* Stable asthma, i.e. no exacerbation or relevant respiratory tract infection within 2 months prior to study start
* FEV1 ≥ 70% predicted
* Hyperreactivity to AMP (PC20FEV1 \< 25 mg/ml)
* Good health with the exception of asthma
* Non-smokers as well as ex-smokers with either = 10 pack-years or more than 6 months of smoking abstinence

Exclusion Criteria

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e.g. lung tuberculosis)
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
* Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
* Pregnancy or intention to become pregnant during the course of the study, breast feeding, lack of safe contraception in heterosexually active female patients of child-bearing potential, or postmenopausal for less than one year
* COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases
* Known or suspected hypersensitivity to inhaled steroids or to the other excipients of the metered dose inhalers
* Immunotherapy within one month prior to B0 and/or during the entire study duration

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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"

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BY9010/M1-125

Identifier Type: -

Identifier Source: org_study_id