Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)

NCT ID: NCT00163436

Last Updated: 2016-11-30

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

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-01-31

Brief Summary

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The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma Ciclesonide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ciclesonide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* History of persistent bronchial asthma for at least 6 months
* Good health with the exception of asthma

Exclusion Criteria

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Smoking history with ≥10 cigarette pack years
* Pregnancy
* Intention to become pregnant
* Breast feeding
* Lack of safe contraception
* Previous enrolment into the current study
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

La Malbaie, Quebec, , Canada

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Altana Pharma/Nycomed

London, , Canada

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Altana Pharma/Nycomed

London,ON, , Canada

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Altana Pharma/Nycomed

Mississauga, , Canada

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Altana Pharma/Nycomed

Montreal, Quebec, , Canada

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Altana Pharma/Nycomed

Québec, , Canada

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Altana Pharma/Nycomed

Richmond Hill, , Canada

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Altana Pharma/Nycomed

Sainte-Foy, Quebec, , Canada

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Altana Pharma/Nycomed

Saskatoon,SK, , Canada

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Altana Pharma/Nycomed

Scarborough,ON, , Canada

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Altana Pharma/Nycomed

Toronto, , Canada

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Altana Pharma/Nycomed

Vancouver, BC, , Canada

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Altana Pharma/Nycomed

Winnipeg, , Canada

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Altana Pharma/Nycomed

Winnipeg MB, , Canada

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Altana Pharma/Nycomed

Woodstock, , Canada

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Altana Pharma/Nycomed

Aix-en-Provence, , France

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Altana Pharma/Nycomed

Chauny, , France

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Altana Pharma/Nycomed

Ferolles-Attily, , France

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Altana Pharma/Nycomed

Grasse, , France

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Altana Pharma/Nycomed

La Rochelle, , France

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Altana Pharma/Nycomed

La Teste-de-Buch, , France

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Altana Pharma/Nycomed

Libourne, , France

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Altana Pharma/Nycomed

Lille, , France

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Altana Pharma/Nycomed

Martigues, , France

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Altana Pharma/Nycomed

Montbrison, , France

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Altana Pharma/Nycomed

Montpellier, , France

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Altana Pharma/Nycomed

Nice, , France

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Altana Pharma/Nycomed

Nîmes, , France

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Altana Pharma/Nycomed

Saint-Laurent-du-Var, , France

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Altana Pharma/Nycomed

Saint-Quentin, , France

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Altana Pharma/Nycomed

Berlin, , Germany

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Altana Pharma/Nycomed

Berlin, , Germany

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Altana Pharma/Nycomed

Oschersleben, , Germany

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Altana Pharma/Nycomed

Rüdersdorf, , Germany

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Altana Pharma/Nycomed

Schwetzingen, , Germany

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Altana Pharma/Nycomed

Weinheim, , Germany

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Altana Pharma/Nycomed

Balassagyarmat, , Hungary

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Altana Pharma/Nycomed

Budapest, , Hungary

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Altana Pharma/Nycomed

Budapest, , Hungary

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Altana Pharma/Nycomed

Budapet, , Hungary

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Altana Pharma/Nycomed

Érd, , Hungary

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Altana Pharma/Nycomed

Gyula, , Hungary

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Altana Pharma/Nycomed

Komárom, , Hungary

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Altana Pharma/Nycomed

Miskolc, , Hungary

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Altana Pharma/Nycomed

Mosdós, , Hungary

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Altana Pharma/Nycomed

Nyiregyháza, , Hungary

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Altana Pharma/Nycomed

Pécs, , Hungary

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Altana Pharma/Nycomed

Szeged, , Hungary

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Altana Pharma/Nycomed

Székesfehérvár, , Hungary

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Altana Pharma/Nycomed

Bangalore, , India

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Altana Pharma/Nycomed

Chennai, , India

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Altana Pharma/Nycomed

Coimbatore, , India

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Altana Pharma/Nycomed

Coimbatore, , India

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Altana Pharma/Nycomed

Coimbatore, Tamilnadu, , India

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Altana Pharma/Nycomed

Goa, , India

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Altana Pharma/Nycomed

Kalaburagi, , India

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Altana Pharma/Nycomed

Mumbai, , India

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Altana Pharma/Nycomed

Mumbai, Dadar (E), , India

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Altana Pharma/Nycomed

Pune, , India

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Altana Pharma/Nycomed

Florence, , Italy

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Altana Pharma/Nycomed

Milan, , Italy

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Altana Pharma/Nycomed

Milan, , Italy

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Altana Pharma/Nycomed

Milan, , Italy

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Altana Pharma/Nycomed

Napoli, , Italy

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Altana Pharma/Nycomed

Pordenone, , Italy

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Altana Pharma/Nycomed

Verona, , Italy

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Countries

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Canada France Germany Hungary India Italy

Related Links

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Other Identifiers

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BY9010/M1-145

Identifier Type: -

Identifier Source: org_study_id