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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00163358
Registration number
NCT00163358
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
30/11/2016
Titles & IDs
Public title
Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)
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Scientific title
Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control
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Secondary ID [1]
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0
BY9010/M1-132
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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0
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0
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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time until the first severe asthma exacerbation occurs
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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number of poorly controlled asthma days.
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [1]
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percentage of days with asthma control
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Assessment method [1]
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0
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Timepoint [1]
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Secondary outcome [2]
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percentage of days with asthma symptoms
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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percentage of nocturnal awakenings due to asthma
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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asthma symptom score
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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number of inhalations of rescue medication
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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proportion of patients with severe asthma exacerbations
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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differences in morning PEF from diary
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Timepoint [7]
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Secondary outcome [8]
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differences in FEV1 and FVC from spirometry
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Assessment method [8]
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Timepoint [8]
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Secondary outcome [9]
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blood eosinophils
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Timepoint [9]
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Secondary outcome [10]
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AQLQ(S)
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Timepoint [10]
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Secondary outcome [11]
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health economic data
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Timepoint [11]
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Secondary outcome [12]
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vital signs
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Timepoint [12]
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Secondary outcome [13]
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laboratory work-up
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Timepoint [13]
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Secondary outcome [14]
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adverse events.
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Assessment method [14]
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Timepoint [14]
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Eligibility
Key inclusion criteria
Main
* Clinical diagnosis of mild persistent asthma
* Pre-treatment with SABAs only
* FEV1 =80% predicted
* Good health with the exception of asthma
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Minimum age
12
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 pulmonary function
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception
* Current smokers =10 pack-years and ex-smokers with =10 pack-years
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2005
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Altana Pharma/Nycomed - Adelaide South Australia
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Altana Pharma/Nycomed - Auchenflower
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Altana Pharma/Nycomed - Bracken Ridge
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Altana Pharma/Nycomed - Burwood
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Altana Pharma/Nycomed - Camperdown
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Altana Pharma/Nycomed - Clayton
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Altana Pharma/Nycomed - Toorak Gardens
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Altana Pharma/Nycomed - Wayville
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5000 - Adelaide South Australia
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Recruitment postcode(s) [2]
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QLD 4066 - Auchenflower
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QLD 4017 - Bracken Ridge
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NSW 2134 - Burwood
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NSW 2050 - Camperdown
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QLD 4152 - Carina Heights
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VIC 3168 - Clayton
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2139 - Concord
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VIC 3220 - Geelong
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QLD 4077 - Inala
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QLD 4021 - Kippa-ring
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WA 6009 - Nedlands
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VIC 3939 - Rosebud
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QLD 4101 - South Brisbane
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SA 5056 - Toorak Gardens
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SA 5034 - Wayville
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Recruitment outside Australia
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Canada
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Beaconsfield, QC
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Coquitlam, BC
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George
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Midrand
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Pretoria
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Santiago de Compostela
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Spain
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
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Trial website
https://clinicaltrials.gov/study/NCT00163358
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Trial related presentations / publications
Postma DS, O'Byrne PM, Pedersen S. Comparison of the effect of low-dose ciclesonide and fixed-dose fluticasone propionate and salmeterol combination on long-term asthma control. Chest. 2011 Feb;139(2):311-318. doi: 10.1378/chest.09-1735. Epub 2010 Nov 18.
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Public notes
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Contacts
Principal investigator
Name
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AstraZeneca AstraZeneca
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Address
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AstraZeneca
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00163358
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