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Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)

NCT ID: NCT00163332

Last Updated: 2016-12-06

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Brief Summary

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The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 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 Fluticasone propionate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ciclesonide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have had a history of bronchial asthma for at least 6 months
* FEV1 \>60% of predicted for at least 24 h
* Patients who are hyperresponsive to methacholine and to AMP
* Patients who are in good health with the exception of asthma

Exclusion Criteria

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Patients suffering from COPD and/or other relevant lung diseases except asthma
* Current smokers and ex-smokers both with ≥10 pack years
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Genk, , Belgium

Site Status

Altana Pharma/Nycomed

Ghent, , Belgium

Site Status

Altana Pharma/Nycomed

Lanaken, , Belgium

Site Status

Altana Pharma/Nycomed

Liège, , Belgium

Site Status

Altana Pharma/Nycomed

Liége, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4517&filename=BY9010-MI-129-RDS-2007-04-25.pdf

BY9010-MI-129-RDS-2007-04-25.pdf

Other Identifiers

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BY9010/M1-129

Identifier Type: -

Identifier Source: org_study_id