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Effectiveness of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-136)

NCT ID: NCT00163384

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

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-05-31

Brief Summary

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This trial will compare the effectiveness of one dose of ciclesonide against one dose of budesonide in patients with asthma.

The aim of the present trial is to compare the efficacy of ciclesonide versus budesonide on pulmonary function, symptoms and use of rescue medication in patients with asthma. The onset of action and the safety and tolerability of ciclesonide in comparison to budesonide will also be investigated.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma Ciclesonide Budesonide

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

* During the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent)
* FEV1 80 - 105% of predicted
* Healthy with the exception of asthma
* Written informed consent has been obtained
* Outpatients
* Patients who have a history of persistent bronchial asthma for at least 6 months

Exclusion Criteria

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Concomitant COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
* An asthma exacerbation or an infection of the lower airways prior to entry into the baseline period
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception
* Patient is current smoker with 10 or more pack-years
* Patient is ex-smoker with 10 or more pack-years
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

Busan, , South Korea

Site Status

Altana Pharma/Nycomed

Daegu, , South Korea

Site Status

Altana Pharma/Nycomed

Daegu, , South Korea

Site Status

Altana Pharma/Nycomed

Daejeon, , South Korea

Site Status

Altana Pharma/Nycomed

Gangwon-do, , South Korea

Site Status

Altana Pharma/Nycomed

Gwangju, , South Korea

Site Status

Altana Pharma/Nycomed

Gyeonggi-do, , South Korea

Site Status

Altana Pharma/Nycomed

Gyeonggi-do, , South Korea

Site Status

Altana Pharma/Nycomed

Jeonju, , South Korea

Site Status

Altana Pharma/Nycomed

Jungbuk, , South Korea

Site Status

Altana Pharma/Nycomed

Jungnam, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Altana Pharma/Nycomed

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4521&filename=BY9010-M1-136-RDS-2006-12-03.pdf

BY9010-M1-136-RDS-2006-12-03.pdf

Other Identifiers

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BY9010/M1-136

Identifier Type: -

Identifier Source: org_study_id