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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)
Scientific title
Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control
Secondary ID [1] 0 0
BY9010/M1-132
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
time until the first severe asthma exacerbation occurs
Timepoint [1] 0 0
Primary outcome [2] 0 0
number of poorly controlled asthma days.
Timepoint [2] 0 0
Secondary outcome [1] 0 0
percentage of days with asthma control
Timepoint [1] 0 0
Secondary outcome [2] 0 0
percentage of days with asthma symptoms
Timepoint [2] 0 0
Secondary outcome [3] 0 0
percentage of nocturnal awakenings due to asthma
Timepoint [3] 0 0
Secondary outcome [4] 0 0
asthma symptom score
Timepoint [4] 0 0
Secondary outcome [5] 0 0
number of inhalations of rescue medication
Timepoint [5] 0 0
Secondary outcome [6] 0 0
proportion of patients with severe asthma exacerbations
Timepoint [6] 0 0
Secondary outcome [7] 0 0
differences in morning PEF from diary
Timepoint [7] 0 0
Secondary outcome [8] 0 0
differences in FEV1 and FVC from spirometry
Timepoint [8] 0 0
Secondary outcome [9] 0 0
blood eosinophils
Timepoint [9] 0 0
Secondary outcome [10] 0 0
AQLQ(S)
Timepoint [10] 0 0
Secondary outcome [11] 0 0
health economic data
Timepoint [11] 0 0
Secondary outcome [12] 0 0
vital signs
Timepoint [12] 0 0
Secondary outcome [13] 0 0
laboratory work-up
Timepoint [13] 0 0
Secondary outcome [14] 0 0
adverse events.
Timepoint [14] 0 0

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

Main
Minimum age
12 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Altana Pharma/Nycomed - Adelaide South Australia
Recruitment hospital [2] 0 0
Altana Pharma/Nycomed - Auchenflower
Recruitment hospital [3] 0 0
Altana Pharma/Nycomed - Bracken Ridge
Recruitment hospital [4] 0 0
Altana Pharma/Nycomed - Burwood
Recruitment hospital [5] 0 0
Altana Pharma/Nycomed - Camperdown
Recruitment hospital [6] 0 0
Altana Pharma/Nycomed - Carina Heights
Recruitment hospital [7] 0 0
Altana Pharma/Nycomed - Clayton
Recruitment hospital [8] 0 0
Altana Pharma/Nycomed - Concord
Recruitment hospital [9] 0 0
Altana Pharma/Nycomed - Geelong
Recruitment hospital [10] 0 0
Altana Pharma/Nycomed - Inala
Recruitment hospital [11] 0 0
Altana Pharma/Nycomed - Kippa-ring
Recruitment hospital [12] 0 0
Altana Pharma/Nycomed - Nedlands
Recruitment hospital [13] 0 0
Altana Pharma/Nycomed - Rosebud
Recruitment hospital [14] 0 0
Altana Pharma/Nycomed - South Brisbane
Recruitment hospital [15] 0 0
Altana Pharma/Nycomed - Toorak Gardens
Recruitment hospital [16] 0 0
Altana Pharma/Nycomed - Wayville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide South Australia
Recruitment postcode(s) [2] 0 0
QLD 4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
QLD 4017 - Bracken Ridge
Recruitment postcode(s) [4] 0 0
NSW 2134 - Burwood
Recruitment postcode(s) [5] 0 0
NSW 2050 - Camperdown
Recruitment postcode(s) [6] 0 0
QLD 4152 - Carina Heights
Recruitment postcode(s) [7] 0 0
VIC 3168 - Clayton
Recruitment postcode(s) [8] 0 0
2139 - Concord
Recruitment postcode(s) [9] 0 0
VIC 3220 - Geelong
Recruitment postcode(s) [10] 0 0
QLD 4077 - Inala
Recruitment postcode(s) [11] 0 0
QLD 4021 - Kippa-ring
Recruitment postcode(s) [12] 0 0
WA 6009 - Nedlands
Recruitment postcode(s) [13] 0 0
VIC 3939 - Rosebud
Recruitment postcode(s) [14] 0 0
QLD 4101 - South Brisbane
Recruitment postcode(s) [15] 0 0
SA 5056 - Toorak Gardens
Recruitment postcode(s) [16] 0 0
SA 5034 - Wayville
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Beaconsfield, QC
Country [2] 0 0
Canada
State/province [2] 0 0
Coquitlam, BC
Country [3] 0 0
Canada
State/province [3] 0 0
Coquitlam
Country [4] 0 0
Canada
State/province [4] 0 0
Corner Brook
Country [5] 0 0
Canada
State/province [5] 0 0
Cowansville
Country [6] 0 0
Canada
State/province [6] 0 0
Kingston, Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Langley BC
Country [8] 0 0
Canada
State/province [8] 0 0
Laval
Country [9] 0 0
Canada
State/province [9] 0 0
Les Saules, QC
Country [10] 0 0
Canada
State/province [10] 0 0
Longueuil, PQ
Country [11] 0 0
Canada
State/province [11] 0 0
Montreal, PQ
Country [12] 0 0
Canada
State/province [12] 0 0
Montreal
Country [13] 0 0
Canada
State/province [13] 0 0
North Bay
Country [14] 0 0
Canada
State/province [14] 0 0
North York
Country [15] 0 0
Canada
State/province [15] 0 0
Ottawa
Country [16] 0 0
Canada
State/province [16] 0 0
Penticton, BC
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec City
Country [18] 0 0
Canada
State/province [18] 0 0
Saint John's
Country [19] 0 0
Canada
State/province [19] 0 0
Saint John
Country [20] 0 0
Canada
State/province [20] 0 0
Sainte-Foy, Quebec
Country [21] 0 0
Canada
State/province [21] 0 0
Saskatoon, SK
Country [22] 0 0
Canada
State/province [22] 0 0
St. John's
Country [23] 0 0
Canada
State/province [23] 0 0
Ste-Foy PQ
Country [24] 0 0
Canada
State/province [24] 0 0
Toronto ON
Country [25] 0 0
Canada
State/province [25] 0 0
Toronto
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Beroun
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Ceska Lipa
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Cvikov
Country [29] 0 0
Czech Republic
State/province [29] 0 0
Havlickuv
Country [30] 0 0
Czech Republic
State/province [30] 0 0
Jihlava
Country [31] 0 0
Czech Republic
State/province [31] 0 0
Jindrichuv Hradec
Country [32] 0 0
Czech Republic
State/province [32] 0 0
Karlovy Vary
Country [33] 0 0
Czech Republic
State/province [33] 0 0
Kladno
Country [34] 0 0
Czech Republic
State/province [34] 0 0
Kutná Hora
Country [35] 0 0
Czech Republic
State/province [35] 0 0
Ostrava-Marián.Hory
Country [36] 0 0
Czech Republic
State/province [36] 0 0
Praha 10
Country [37] 0 0
Czech Republic
State/province [37] 0 0
Praha 2
Country [38] 0 0
Czech Republic
State/province [38] 0 0
Praha 4
Country [39] 0 0
Czech Republic
State/province [39] 0 0
Praha 8
Country [40] 0 0
Czech Republic
State/province [40] 0 0
Praha 9
Country [41] 0 0
Czech Republic
State/province [41] 0 0
Pribram VI
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Príbram VIII
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Rokycany
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Strakonice
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Trutnov
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Usti nad Labem
Country [47] 0 0
Hungary
State/province [47] 0 0
Budapest XI
Country [48] 0 0
Hungary
State/province [48] 0 0
Budapest
Country [49] 0 0
Hungary
State/province [49] 0 0
Budapet
Country [50] 0 0
Hungary
State/province [50] 0 0
Kecskemet
Country [51] 0 0
Hungary
State/province [51] 0 0
Nyíregyháza
Country [52] 0 0
Hungary
State/province [52] 0 0
Szarvas
Country [53] 0 0
Hungary
State/province [53] 0 0
Tatabanya
Country [54] 0 0
Poland
State/province [54] 0 0
Bydgoszcz
Country [55] 0 0
Poland
State/province [55] 0 0
Lodz
Country [56] 0 0
Poland
State/province [56] 0 0
Lódz'
Country [57] 0 0
Poland
State/province [57] 0 0
Rzeszow
Country [58] 0 0
Poland
State/province [58] 0 0
Warszawa
Country [59] 0 0
Poland
State/province [59] 0 0
Wroclaw
Country [60] 0 0
South Africa
State/province [60] 0 0
Arcadia, Pretoria
Country [61] 0 0
South Africa
State/province [61] 0 0
Bellville, Cape Town
Country [62] 0 0
South Africa
State/province [62] 0 0
Berea, Durban
Country [63] 0 0
South Africa
State/province [63] 0 0
Bloemfontein
Country [64] 0 0
South Africa
State/province [64] 0 0
Cape Town
Country [65] 0 0
South Africa
State/province [65] 0 0
Centurion, Pretoria
Country [66] 0 0
South Africa
State/province [66] 0 0
Daveyton
Country [67] 0 0
South Africa
State/province [67] 0 0
Durban, Amanzimtoti
Country [68] 0 0
South Africa
State/province [68] 0 0
George
Country [69] 0 0
South Africa
State/province [69] 0 0
Midrand
Country [70] 0 0
South Africa
State/province [70] 0 0
Mowbray, Cape Town
Country [71] 0 0
South Africa
State/province [71] 0 0
Paarl
Country [72] 0 0
South Africa
State/province [72] 0 0
Panorama / RSA-Cape Town
Country [73] 0 0
South Africa
State/province [73] 0 0
Pretoria
Country [74] 0 0
Spain
State/province [74] 0 0
Alcorcón (Madrid)
Country [75] 0 0
Spain
State/province [75] 0 0
Alicante
Country [76] 0 0
Spain
State/province [76] 0 0
Barcelona
Country [77] 0 0
Spain
State/province [77] 0 0
Campdevanol (Girona)
Country [78] 0 0
Spain
State/province [78] 0 0
Elda (Alicante)
Country [79] 0 0
Spain
State/province [79] 0 0
Guadalajara
Country [80] 0 0
Spain
State/province [80] 0 0
Leganes (Madrid)
Country [81] 0 0
Spain
State/province [81] 0 0
Palma de Mallorca
Country [82] 0 0
Spain
State/province [82] 0 0
Peralada (Girona)
Country [83] 0 0
Spain
State/province [83] 0 0
Petrer (Alicante)
Country [84] 0 0
Spain
State/province [84] 0 0
San Vicente del Raspeig (Alicante)
Country [85] 0 0
Spain
State/province [85] 0 0
Santiago de Compostela
Country [86] 0 0
Spain
State/province [86] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca AstraZeneca
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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