Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)

NCT ID: NCT00163462

Last Updated: 2016-12-05

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

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-11-30

Brief Summary

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The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled once daily, using one of the two dose levels; 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 (12 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 Child Fluticasone propionate Pediatric

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

* History of persistent bronchial asthma for at least 6 months
* FEV1 50-90% of predicted

Exclusion Criteria

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
* Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
* History of life-threatening asthma
* Premature birth
* Current smoking
* Smoking history with either equal or more than 10 pack-years
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 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

Campinas - SP, , Brazil

Site Status

Altana Pharma/Nycomed

Curitiba-PR, , Brazil

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Altana Pharma/Nycomed

Florianópolis-SC, , Brazil

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Altana Pharma/Nycomed

Porto Alegre-RS, , Brazil

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Altana Pharma/Nycomed

Porto Alegre-RS, , Brazil

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Altana Pharma/Nycomed

Rio de Janeiro-RJ, , Brazil

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Altana Pharma/Nycomed

Salvador - Bahia, , Brazil

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Altana Pharma/Nycomed

Santo André-SP, , Brazil

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Altana Pharma/Nycomed

Sao Paulo - SP, , Brazil

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Altana Pharma/Nycomed

Sao Paulo-SP, , Brazil

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Altana Pharma/Nycomed

São Paulo-SP, , Brazil

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Altana Pharma/Nycomed

São Paulo-SP, , Brazil

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Altana Pharma/Nycomed

Frankfurt, , Germany

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Altana Pharma/Nycomed

Gaißach Bei Bad Tölz, , Germany

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Altana Pharma/Nycomed

Geesthacht, , Germany

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Altana Pharma/Nycomed

Mainz, , Germany

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Altana Pharma/Nycomed

München, , Germany

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Altana Pharma/Nycomed

München, , Germany

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Altana Pharma/Nycomed

Wesel, , Germany

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Altana Pharma/Nycomed

Wiefelstede, , Germany

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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

Budapest, , Hungary

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Altana Pharma/Nycomed

Debrecen, , Hungary

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Altana Pharma/Nycomed

Jászberény, , 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

Pécs, , Hungary

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Altana Pharma/Nycomed

Törökbálint, , Hungary

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Altana Pharma/Nycomed

Inowrocław, , Poland

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Altana Pharma/Nycomed

Lodz, , Poland

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Altana Pharma/Nycomed

Lublin, , Poland

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Altana Pharma/Nycomed

Poznan, , Poland

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Altana Pharma/Nycomed

Rzeszów, , Poland

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Altana Pharma/Nycomed

Warsaw, , Poland

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Altana Pharma/Nycomed

Warsaw, , Poland

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Altana Pharma/Nycomed

Zawadzkie, , Poland

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Altana Pharma/Nycomed

Amadora, , Portugal

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Altana Pharma/Nycomed

Faro, , Portugal

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Altana Pharma/Nycomed

Guimarães, , Portugal

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Altana Pharma/Nycomed

Lisbon, , Portugal

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Altana Pharma/Nycomed

Lisbon, , Portugal

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Altana Pharma/Nycomed

Lisbon, , Portugal

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Altana Pharma/Nycomed

Matosinhos Municipality, , Portugal

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Altana Pharma/Nycomed

Oliveira de Azeméis, , Portugal

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Altana Pharma/Nycomed

Porto, , Portugal

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Altana Pharma/Nycomed

Porto, , Portugal

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Altana Pharma/Nycomed

Setúbal, , Portugal

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Altana Pharma/Nycomed

Viana do Castelo, , Portugal

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Altana Pharma/Nycomed

Vila Nova de Gaia, , Portugal

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Altana Pharma/Nycomed

Bellville - Cape Town -, , South Africa

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Altana Pharma/Nycomed

Cape Town, , South Africa

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Altana Pharma/Nycomed

Morningside, Sandton, , South Africa

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Altana Pharma/Nycomed

Mowbray, Cape Town, , South Africa

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Altana Pharma/Nycomed

Panorama / RSA-Cape Town, , South Africa

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Altana Pharma/Nycomed

Westville, , South Africa

Site Status

Altana Pharma/Nycomed

Wynberg, , South Africa

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Countries

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Brazil Germany Hungary Poland Portugal South Africa

Related Links

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Other Identifiers

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BY9010/M1-206

Identifier Type: -

Identifier Source: org_study_id