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Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)

NCT ID: NCT00163423

Last Updated: 2016-12-08

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

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-01-31

Brief Summary

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The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 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 Fluticasone propionate

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

* Outpatients
* Written informed consent
* History of bronchial asthma for at least 6 months
* Good health with the exception of asthma
* Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
* FEV1 80 - 105% of predicted

Exclusion Criteria

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
* Current smoking with more than 10 pack-years
* Previous smoking with more than 10 pack-years
* Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

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

Gmünd, , Austria

Site Status

Altana Pharma/Nycomed

Linz, , Austria

Site Status

Altana Pharma/Nycomed

Linz, , Austria

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Altana Pharma/Nycomed

Neusiedl/See, , Austria

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Altana Pharma/Nycomed

Perg, , Austria

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Altana Pharma/Nycomed

Steyr, , Austria

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Altana Pharma/Nycomed

Wiener Neustadt, , Austria

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Altana Pharma/Nycomed

Brandon, , Canada

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Altana Pharma/Nycomed

Hamilton, , Canada

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Altana Pharma/Nycomed

London, , Canada

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Altana Pharma/Nycomed

London, , Canada

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Altana Pharma/Nycomed

Mississauga, , Canada

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Altana Pharma/Nycomed

Montreal, , Canada

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Altana Pharma/Nycomed

Montreal, , Canada

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Altana Pharma/Nycomed

Montreal, Quebec, , Canada

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Altana Pharma/Nycomed

Ottawa, , Canada

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Altana Pharma/Nycomed

Québec, , Canada

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Altana Pharma/Nycomed

Sainte-Foy, Quebec, , Canada

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Altana Pharma/Nycomed

Sarnia, , Canada

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Altana Pharma/Nycomed

Ste-Foy PQ, , Canada

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Altana Pharma/Nycomed

Toronto, , Canada

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Altana Pharma/Nycomed

Woodstock, , Canada

Site Status

Altana Pharma/Nycomed

Geesthacht, , Germany

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Altana Pharma/Nycomed

Hanover, , Germany

Site Status

Altana Pharma/Nycomed

Heidelberg, , Germany

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Altana Pharma/Nycomed

Koblenz, , Germany

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Altana Pharma/Nycomed

Mainz, , Germany

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Altana Pharma/Nycomed

Marburg, , Germany

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Altana Pharma/Nycomed

Sinsheim, , Germany

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Altana Pharma/Nycomed

Witten, , Germany

Site Status

Altana Pharma/Nycomed

Bielsko-Biala, , Poland

Site Status

Altana Pharma/Nycomed

Gdansk, , Poland

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Altana Pharma/Nycomed

Lodz, , Poland

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Altana Pharma/Nycomed

Lubin, , Poland

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Altana Pharma/Nycomed

Lublin, , Poland

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Altana Pharma/Nycomed

Lublin, , Poland

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Altana Pharma/Nycomed

Wałbrzych, , Poland

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Altana Pharma/Nycomed

Zgierz, , Poland

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Altana Pharma/Nycomed

Arcadia, Pretoria, , South Africa

Site Status

Altana Pharma/Nycomed

Bellville, Cape Town, , South Africa

Site Status

Altana Pharma/Nycomed

Cape Town, , South Africa

Site Status

Altana Pharma/Nycomed

Cape Town, Tygerberg, , South Africa

Site Status

Altana Pharma/Nycomed

Durbanville / Cape Town, , South Africa

Site Status

Altana Pharma/Nycomed

Gatesville, Cape Town, , South Africa

Site Status

Altana Pharma/Nycomed

Lyttleton, , South Africa

Site Status

Altana Pharma/Nycomed

Mowbray, Cape Town, , South Africa

Site Status

Altana Pharma/Nycomed

Observatory Cape, , South Africa

Site Status

Altana Pharma/Nycomed

Pretoria, , South Africa

Site Status

Altana Pharma/Nycomed

Pretoria, , South Africa

Site Status

Altana Pharma/Nycomed

Westville, , South Africa

Site Status

Altana Pharma/Nycomed

Wynberg, , South Africa

Site Status

Countries

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Austria Canada Germany Poland South Africa

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4523&filename=BY9010_M1-142%20Synopsis.pdf

BY9010\_M1-142 Synopsis.pdf

Other Identifiers

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BY9010/M1-142

Identifier Type: -

Identifier Source: org_study_id