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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
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.
Trial website
https://clinicaltrials.gov/study/NCT00163358
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00163358