Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)

NCT ID: NCT00163319

Last Updated: 2016-12-02

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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-11-30

Brief Summary

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The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 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

* Written informed consent
* History of bronchial asthma for at least 6 months
* Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination
* FEV1 ≥ 80% of predicted

Exclusion Criteria

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs
* COPD
* Smoking with ≥10 pack-years
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception
Minimum Eligible Age

18 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

Napoli, , Italy

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Altana Pharma/Nycomed

Pavia, , Italy

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Altana Pharma/Nycomed

Pirri-Cagliari, , Italy

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Altana Pharma/Nycomed

Pordenone, , Italy

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Altana Pharma/Nycomed

Roma, , Italy

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Altana Pharma/Nycomed

Verona, , Italy

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Altana Pharma/Nycomed

Almere Stad, , Netherlands

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Altana Pharma/Nycomed

Milazzo (ME), , Italy

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Altana Pharma/Nycomed

Brussels, , Belgium

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Altana Pharma/Nycomed

Brussels, , Belgium

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Altana Pharma/Nycomed

Brussels, , Belgium

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Altana Pharma/Nycomed

Halen, , Belgium

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Altana Pharma/Nycomed

Jette, , Belgium

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Altana Pharma/Nycomed

Maison-Saint-Gérard, , Belgium

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Altana Pharma/Nycomed

Namur, , Belgium

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Altana Pharma/Nycomed

Ostend, , Belgium

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Altana Pharma/Nycomed

Turnhout, , Belgium

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Altana Pharma/Nycomed

Veurne, , Belgium

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Altana Pharma/Nycomed

Aix-en-Provence, , France

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Altana Pharma/Nycomed

Béziers, , France

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Altana Pharma/Nycomed

Chauny, , 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

Marseille, , France

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Altana Pharma/Nycomed

Martigues, , France

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Altana Pharma/Nycomed

Metz, , France

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Altana Pharma/Nycomed

Montfermeil, , 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

Paris, , France

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Altana Pharma/Nycomed

Perpignan, , France

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Altana Pharma/Nycomed

Vieux-Condé, , France

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Altana Pharma/Nycomed

Ancona, , Italy

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Altana Pharma/Nycomed

Brescia, , Italy

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Altana Pharma/Nycomed

Chieti, , Italy

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Altana Pharma/Nycomed

Florence, , Italy

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Altana Pharma/Nycomed

Livorno, , 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

Haarlem, , Netherlands

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Altana Pharma/Nycomed

Harderwijk, , Netherlands

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Altana Pharma/Nycomed

Heerlen, , Netherlands

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Altana Pharma/Nycomed

Helmond, , Netherlands

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Altana Pharma/Nycomed

Schiedam, , Netherlands

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Altana Pharma/Nycomed

Utrecht, , Netherlands

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Altana Pharma/Nycomed

Veldhoven, , Netherlands

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Altana Pharma/Nycomed

Almería, , Spain

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Altana Pharma/Nycomed

Barcelona, , Spain

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Altana Pharma/Nycomed

Córdoba, , Spain

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Altana Pharma/Nycomed

Elche, , Spain

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Altana Pharma/Nycomed

Guadalajara, , Spain

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Altana Pharma/Nycomed

Madrid, , Spain

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Altana Pharma/Nycomed

Madrid, , Spain

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Altana Pharma/Nycomed

Madrid, , Spain

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Altana Pharma/Nycomed

Madrid, , Spain

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Altana Pharma/Nycomed

Requena, , Spain

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Altana Pharma/Nycomed

San Sebastián, , Spain

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Altana Pharma/Nycomed

Valencia, , Spain

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Altana Pharma/Nycomed

Valencia, , Spain

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Altana Pharma/Nycomed

Basel, , Switzerland

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Altana Pharma/Nycomed

Bellinzona, , Switzerland

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Altana Pharma/Nycomed

Bern, , Switzerland

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Altana Pharma/Nycomed

Bruderholz, , Switzerland

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Altana Pharma/Nycomed

La Chauxe-de-Fonds, , Switzerland

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Altana Pharma/Nycomed

Lugano, , Switzerland

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Altana Pharma/Nycomed

Münchenstein, , Switzerland

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Altana Pharma/Nycomed

Münsingen, , Switzerland

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Altana Pharma/Nycomed

Münsterlingen, , Switzerland

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Altana Pharma/Nycomed

Zurich, , Switzerland

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Altana Pharma/Nycomed

Zurich, , Switzerland

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Altana Pharma/Nycomed

Zurich, , Switzerland

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Altana Pharma/Nycomed

Belfast, , United Kingdom

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Altana Pharma/Nycomed

Belfast, Irland, , United Kingdom

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Altana Pharma/Nycomed

Bradford on Avon, Wiltshire, , United Kingdom

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Altana Pharma/Nycomed

Chesterfield Derbyshire, , United Kingdom

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Altana Pharma/Nycomed

Chippenham, Wiltshire, , United Kingdom

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Altana Pharma/Nycomed

Co. Antrim, , United Kingdom

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Altana Pharma/Nycomed

Downpatrick, Northern Ireland, , United Kingdom

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Altana Pharma/Nycomed

Dronfield, , United Kingdom

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Altana Pharma/Nycomed

Glengormley, , United Kingdom

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Altana Pharma/Nycomed

Glengormley Newtownabbey, , United Kingdom

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Altana Pharma/Nycomed

Hastings, , United Kingdom

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Altana Pharma/Nycomed

Maidenhead, Berks, , United Kingdom

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Altana Pharma/Nycomed

Nottingham, , United Kingdom

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Altana Pharma/Nycomed

Nottingham, , United Kingdom

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Altana Pharma/Nycomed

Solihull, , United Kingdom

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Altana Pharma/Nycomed

Warminster Wiltshire, , United Kingdom

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Altana Pharma/Nycomed

Watford, , United Kingdom

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Countries

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Belgium France Italy Netherlands Spain Switzerland United Kingdom

Related Links

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Other Identifiers

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BY9010/IT-101

Identifier Type: -

Identifier Source: org_study_id