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Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)

NCT ID: NCT00314509

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

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-01-31

Brief Summary

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The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). The study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma Ciclesonide Formoterol Fumarate Long-acting beta2-agonists LABA Steroids

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/Formoterol Combination

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Good health with the exception of bronchial asthma (for at least 6 months)
* FEV1 \> 60% to \< 80% of predicted (if pretreated with inhaled steroids only)
* FEV1 \> 60% to ≤ 85% of predicted (if pretreated with inhaled steroids in combination with other asthma controller)

Exclusion Criteria

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or long-acting beta2-agonists
* Chronic obstructive pulmonary disease (COPD), i.e. chronic bronchitis or emphysema, and/or other relevant lung diseases causing alternating impairment in pulmonary function
* Current smoking or cessation of smoking within the last 6 months or previous smoking with a smoking history ≥ 10 cigarette pack-years
* Use of other drugs not allowed
* Pregnancy or intention to become pregnant during the course of the study, breast feeding, or lack of safe contraception in women of childbearing potential
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

Grenoble, , France

Site Status

Altana Pharma/Nycomed

Montpellier, , France

Site Status

Altana Pharma/Nycomed

Berlin, , Germany

Site Status

Altana Pharma/Nycomed

Großhansdorf, , Germany

Site Status

Altana Pharma/Nycomed

Mainz, , Germany

Site Status

Altana Pharma/Nycomed

Rüdersdorf, , Germany

Site Status

Altana Pharma/Nycomed

Wiesbaden, , Germany

Site Status

Altana Pharma/Nycomed

Balassagyarmat, , Hungary

Site Status

Altana Pharma/Nycomed

Balatonfüred, , Hungary

Site Status

Altana Pharma/Nycomed

Budapest, , Hungary

Site Status

Altana Pharma/Nycomed

Budapest, , Hungary

Site Status

Altana Pharma/Nycomed

Csorna, , Hungary

Site Status

Altana Pharma/Nycomed

Debrecen, , Hungary

Site Status

Altana Pharma/Nycomed

Győr, , Hungary

Site Status

Altana Pharma/Nycomed

Mátraháza, , Hungary

Site Status

Altana Pharma/Nycomed

Mosonmagyaróvár, , Hungary

Site Status

Altana Pharma/Nycomed

Nyíregyháza, , Hungary

Site Status

Altana Pharma/Nycomed

Szolnok, , Hungary

Site Status

Altana Pharma/Nycomed

Szombathely, , Hungary

Site Status

Altana Pharma/Nycomed

Arcadia, Pretoria, , South Africa

Site Status

Altana Pharma/Nycomed

Bellville, Cape Town, , South Africa

Site Status

Altana Pharma/Nycomed

Bloemfontein, , South Africa

Site Status

Altana Pharma/Nycomed

Cape Town, Tygerberg, , South Africa

Site Status

Altana Pharma/Nycomed

Mowbray, Cape Town, , South Africa

Site Status

Altana Pharma/Nycomed

Panorama / RSA-Cape Town, , South Africa

Site Status

Altana Pharma/Nycomed

Pretoria, , South Africa

Site Status

Countries

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France Germany Hungary South Africa

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4546&filename=BY9010%20M1-506.pdf

BY9010 M1-506.pdf

Other Identifiers

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BY9010/M1-506

Identifier Type: -

Identifier Source: org_study_id