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Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)

NCT ID: NCT00305461

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

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-02-29

Brief Summary

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The aim of the study is to compare the effect of ciclesonide on quality of life, pulmonary function and time to first exacerbation in patients with moderate persistent asthma. Ciclesonide will be administered once daily in the evening at two dose levels. The study duration consists of a baseline period (2 weeks) and a treatment period (8 weeks).

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma Quality of Life Ciclesonide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Ciclesonide 160µg

Group Type ACTIVE_COMPARATOR

Ciclesonide

Intervention Type DRUG

Effect of Ciclesonide on Quality of Life

2

Ciclesonide 320µg

Group Type ACTIVE_COMPARATOR

Ciclesonide

Intervention Type DRUG

Effect of Ciclesonide on Quality of Life

Interventions

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Ciclesonide

Effect of Ciclesonide on Quality of Life

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Good health with the exception of asthma
* Clinical diagnosis of moderate persistent asthma during the last 6 months prior to visit B0
* Pre-treatment with inhaled corticosteroids dose equivalent to 250 - 500 mcg BDP / day at stable dosing during the last 4 weeks prior to visit B0, concomitant or not to short-acting beta2-agonists treatment as rescue medication
* FEV1 ≥ 70% and ≤ 90% predicted measured at least 4 h after the last use of rescue medication at visit B0
* Reversibility ≥ 12% and ≥ 200 mL in B0, B0 or T0, after inhalation of 400 mcg of salbutamol
* Patients compliant to recommended pre-treatment

Exclusion Criteria

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Chronic obstructive pulmonary disease (COPD)
* Hospitalization within previous four weeks from baseline
* Hospitalization due to asthma within the last twelve months
* Asthma exacerbation within two months previous to baseline
* History of almost fatal asthma at any moment
* Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
* Exacerbation of asthma within 2 months prior to entry into the baseline period
* Use of systemic steroids up to 2 months (injectable depot steroids 6 months) before entry into the baseline period, or more than 3 times during the last 6 months
Minimum Eligible Age

21 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

Buenos Aires, , Argentina

Site Status

Altana Pharma/Nycomed

Buenos Aires, , Argentina

Site Status

Altana Pharma/Nycomed

Buenos Aires, , Argentina

Site Status

Altana Pharma/Nycomed

Cap. Fed., , Argentina

Site Status

Altana Pharma/Nycomed

Cap. Fed., , Argentina

Site Status

Altana Pharma/Nycomed

Cap. Fed., , Argentina

Site Status

Altana Pharma/Nycomed

Cap. Fed., , Argentina

Site Status

Altana Pharma/Nycomed

Córdoba, , Argentina

Site Status

Altana Pharma/Nycomed

Córdoba, , Argentina

Site Status

Altana Pharma/Nycomed

Mendoza, , Argentina

Site Status

Altana Pharma/Nycomed

San Miguel de Tucumán, , Argentina

Site Status

Altana Pharma/Nycomed

Santa Fe, , Argentina

Site Status

Countries

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Argentina

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4506&filename=BY9010-AR-101-RDS-2009-06-19.pdf

BY9010-AR-101-RDS-2009-06-19.pdf

Other Identifiers

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BY9010/AR-101

Identifier Type: -

Identifier Source: org_study_id