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Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)

NCT ID: NCT00163410

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

2003-04-30

Study Completion Date

2004-12-31

Brief Summary

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The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent 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 (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

4 Years

Maximum Eligible Age

15 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

Ahmedabad, , India

Site Status

Altana Pharma/Nycomed

Bangalore, , India

Site Status

Altana Pharma/Nycomed

Chandigarh, , India

Site Status

Altana Pharma/Nycomed

Coimbatore, , India

Site Status

Altana Pharma/Nycomed

Coimbatore, , India

Site Status

Altana Pharma/Nycomed

Coimbatore, Tamilnadu, , India

Site Status

Altana Pharma/Nycomed

Delhi, , India

Site Status

Altana Pharma/Nycomed

Kolkata, , India

Site Status

Altana Pharma/Nycomed

Mumbai, , India

Site Status

Altana Pharma/Nycomed

Mumbai, , India

Site Status

Altana Pharma/Nycomed

Mumbai, , India

Site Status

Altana Pharma/Nycomed

Mumbai, , India

Site Status

Altana Pharma/Nycomed

Pune, , India

Site Status

Altana Pharma/Nycomed

Pune, , India

Site Status

Altana Pharma/Nycomed

Pune, , India

Site Status

Altana Pharma/Nycomed

Shastri Nagar, Jaipur, , India

Site Status

Countries

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India

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4525&filename=BY9010_M1-205%20Synopsis.AZCT.com%20posting.pdf

BY9010\_M1-205 Synopsis

Other Identifiers

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BY9010/M1-205

Identifier Type: -

Identifier Source: org_study_id