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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00242775




Registration number
NCT00242775
Ethics application status
Date submitted
20/10/2005
Date registered
21/10/2005
Date last updated
24/01/2011

Titles & IDs
Public title
Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mg
Scientific title
Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus As-needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 mg/Inhalation As-needed - a 6-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD).
Secondary ID [1] 0 0
EurodraCT No. 2004-004905-11
Secondary ID [2] 0 0
D5890C00002
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
Treatment: Drugs - Budesonide/formoterol Turbuhaler
Treatment: Drugs - Salmeterol/fluticasone Diskus

Treatment: Drugs: Budesonide/formoterol Turbuhaler


Treatment: Drugs: Salmeterol/fluticasone Diskus
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first severe asthma exacerbation
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Number of severe asthma exacerbations
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Mild asthma exacerbations
Timepoint [2] 0 0
Secondary outcome [3] 0 0
FEV1
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Healthcare utilization
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Safety (adverse events)
Timepoint [6] 0 0
Secondary outcome [7] 0 0
- all variables assessed over the 6 months treatment period
Timepoint [7] 0 0

Eligibility
Key inclusion criteria
- Diagnosed with asthma since at least 6 months prior to first visit

- Prescribed daily use of glucocorticosteroids for at least 3 months prior to first
visit

- At least one asthma exacerbation more than one but less than twelve months prior to
first visit
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Respiratory infection affecting asthma within 30 days before first visit

- Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before
first visit

- Any significant disease or disorder that may jeopardize the safety of the patient

Additional inclusion and exclusion criteria will be evaluated by the Investigator.

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
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Bankstown
Recruitment hospital [2] 0 0
Research Site - Sydney
Recruitment hospital [3] 0 0
Research Site - Westmead
Recruitment hospital [4] 0 0
Research Site - Bundaberg
Recruitment hospital [5] 0 0
Research Site - Carina Heights
Recruitment hospital [6] 0 0
Research Site - Mackay
Recruitment hospital [7] 0 0
Research Site - Ashford
Recruitment hospital [8] 0 0
Research Site - Toorak Gardens
Recruitment hospital [9] 0 0
Research Site - Woodville South
Recruitment hospital [10] 0 0
Research Site - Box Hill
Recruitment hospital [11] 0 0
Research Site - Malvern
Recruitment hospital [12] 0 0
Research Site - Prahran
Recruitment hospital [13] 0 0
Research Site - Rosebud
Recruitment hospital [14] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Bankstown
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Bundaberg
Recruitment postcode(s) [5] 0 0
- Carina Heights
Recruitment postcode(s) [6] 0 0
- Mackay
Recruitment postcode(s) [7] 0 0
- Ashford
Recruitment postcode(s) [8] 0 0
- Toorak Gardens
Recruitment postcode(s) [9] 0 0
- Woodville South
Recruitment postcode(s) [10] 0 0
- Box Hill
Recruitment postcode(s) [11] 0 0
- Malvern
Recruitment postcode(s) [12] 0 0
- Prahran
Recruitment postcode(s) [13] 0 0
- Rosebud
Recruitment postcode(s) [14] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Provincia De Tucuman
Country [3] 0 0
Argentina
State/province [3] 0 0
Cordoba
Country [4] 0 0
Argentina
State/province [4] 0 0
Santa Fé
Country [5] 0 0
Argentina
State/province [5] 0 0
Tucuman
Country [6] 0 0
Brazil
State/province [6] 0 0
Bahia
Country [7] 0 0
Brazil
State/province [7] 0 0
MG
Country [8] 0 0
Brazil
State/province [8] 0 0
Pernambuco
Country [9] 0 0
Brazil
State/province [9] 0 0
RJ
Country [10] 0 0
Brazil
State/province [10] 0 0
Santa Catarina
Country [11] 0 0
Brazil
State/province [11] 0 0
SP
Country [12] 0 0
Brazil
State/province [12] 0 0
Curitiba
Country [13] 0 0
Brazil
State/province [13] 0 0
Sao Paulo
Country [14] 0 0
Brazil
State/province [14] 0 0
São Paulo
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
Manitoba
Country [17] 0 0
Canada
State/province [17] 0 0
Newfoundland and Labrador
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Canada
State/province [20] 0 0
Saskatchewan
Country [21] 0 0
China
State/province [21] 0 0
Beijing
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China
State/province [22] 0 0
Guang Zhou
Country [23] 0 0
China
State/province [23] 0 0
Nan Jin
Country [24] 0 0
China
State/province [24] 0 0
Shanghai
Country [25] 0 0
China
State/province [25] 0 0
Shanxi
Country [26] 0 0
China
State/province [26] 0 0
Shenyang
Country [27] 0 0
France
State/province [27] 0 0
Angers
Country [28] 0 0
France
State/province [28] 0 0
Bernay
Country [29] 0 0
France
State/province [29] 0 0
Bethune
Country [30] 0 0
France
State/province [30] 0 0
Chamalieres
Country [31] 0 0
France
State/province [31] 0 0
Ferolles Attilly
Country [32] 0 0
France
State/province [32] 0 0
Grasse
Country [33] 0 0
France
State/province [33] 0 0
Henin Beaumont
Country [34] 0 0
France
State/province [34] 0 0
La Rochelle
Country [35] 0 0
France
State/province [35] 0 0
Laon
Country [36] 0 0
France
State/province [36] 0 0
Le Havre
Country [37] 0 0
France
State/province [37] 0 0
Lille
Country [38] 0 0
France
State/province [38] 0 0
Lorient
Country [39] 0 0
France
State/province [39] 0 0
MARSEILLE Cedex 06
Country [40] 0 0
France
State/province [40] 0 0
Montereau Fault Yonne
Country [41] 0 0
France
State/province [41] 0 0
Montpellier
Country [42] 0 0
France
State/province [42] 0 0
Nantes
Country [43] 0 0
France
State/province [43] 0 0
NIMES Cedex 9
Country [44] 0 0
France
State/province [44] 0 0
Paris
Country [45] 0 0
France
State/province [45] 0 0
Saint Denis
Country [46] 0 0
France
State/province [46] 0 0
Selestat
Country [47] 0 0
France
State/province [47] 0 0
St Laurent Du Var
Country [48] 0 0
France
State/province [48] 0 0
Toulouse Cedex 9
Country [49] 0 0
France
State/province [49] 0 0
Villebon Sur Yvette
Country [50] 0 0
France
State/province [50] 0 0
Villejuif
Country [51] 0 0
Germany
State/province [51] 0 0
Brandenburg
Country [52] 0 0
Germany
State/province [52] 0 0
Hessen
Country [53] 0 0
Germany
State/province [53] 0 0
Nordrhein-Westfalen
Country [54] 0 0
Germany
State/province [54] 0 0
Schleswig-Holstein
Country [55] 0 0
Germany
State/province [55] 0 0
Thüringen
Country [56] 0 0
Germany
State/province [56] 0 0
Berlin
Country [57] 0 0
Germany
State/province [57] 0 0
Bonn
Country [58] 0 0
Germany
State/province [58] 0 0
Düsseldorf
Country [59] 0 0
Germany
State/province [59] 0 0
Erfurt
Country [60] 0 0
Germany
State/province [60] 0 0
Geesthacht
Country [61] 0 0
Germany
State/province [61] 0 0
Großhansdorf
Country [62] 0 0
Germany
State/province [62] 0 0
Hagen
Country [63] 0 0
Germany
State/province [63] 0 0
Hamburg
Country [64] 0 0
Germany
State/province [64] 0 0
Kassel
Country [65] 0 0
Germany
State/province [65] 0 0
Koblenz
Country [66] 0 0
Germany
State/province [66] 0 0
Lübeck
Country [67] 0 0
Germany
State/province [67] 0 0
Marburg
Country [68] 0 0
Germany
State/province [68] 0 0
Neuruppin
Country [69] 0 0
Germany
State/province [69] 0 0
Sonneberg
Country [70] 0 0
Germany
State/province [70] 0 0
Witten
Country [71] 0 0
India
State/province [71] 0 0
Coimbatore
Country [72] 0 0
India
State/province [72] 0 0
Hyderbad
Country [73] 0 0
India
State/province [73] 0 0
Mumbai
Country [74] 0 0
India
State/province [74] 0 0
Noida
Country [75] 0 0
Indonesia
State/province [75] 0 0
Jakarta - Indonesia
Country [76] 0 0
Indonesia
State/province [76] 0 0
Jawa Tengah
Country [77] 0 0
Indonesia
State/province [77] 0 0
Bandung
Country [78] 0 0
Indonesia
State/province [78] 0 0
Jakarta Timur
Country [79] 0 0
Indonesia
State/province [79] 0 0
Jakarta
Country [80] 0 0
Indonesia
State/province [80] 0 0
Solo
Country [81] 0 0
Malaysia
State/province [81] 0 0
Kuala Lumpur
Country [82] 0 0
Malaysia
State/province [82] 0 0
Seremban
Country [83] 0 0
Mexico
State/province [83] 0 0
Jalisco
Country [84] 0 0
Mexico
State/province [84] 0 0
Tabasco
Country [85] 0 0
Mexico
State/province [85] 0 0
Mexico
Country [86] 0 0
Philippines
State/province [86] 0 0
Cebu City
Country [87] 0 0
Philippines
State/province [87] 0 0
Iloilo City
Country [88] 0 0
Philippines
State/province [88] 0 0
Quezon City
Country [89] 0 0
Singapore
State/province [89] 0 0
Singapore
Country [90] 0 0
South Africa
State/province [90] 0 0
Gauteng
Country [91] 0 0
South Africa
State/province [91] 0 0
Pretoria
Country [92] 0 0
South Africa
State/province [92] 0 0
Bellville
Country [93] 0 0
South Africa
State/province [93] 0 0
Bloemfontein
Country [94] 0 0
South Africa
State/province [94] 0 0
Cape Town
Country [95] 0 0
South Africa
State/province [95] 0 0
Durban
Country [96] 0 0
South Africa
State/province [96] 0 0
Johannesburg
Country [97] 0 0
South Africa
State/province [97] 0 0
Lyttelton Manor
Country [98] 0 0
South Africa
State/province [98] 0 0
Umkomaas
Country [99] 0 0
Spain
State/province [99] 0 0
Guipuzcoa
Country [100] 0 0
Spain
State/province [100] 0 0
Murcia
Country [101] 0 0
Spain
State/province [101] 0 0
Barcelona
Country [102] 0 0
Spain
State/province [102] 0 0
Granada
Country [103] 0 0
Spain
State/province [103] 0 0
Jaén
Country [104] 0 0
Spain
State/province [104] 0 0
Madrid
Country [105] 0 0
Spain
State/province [105] 0 0
Santander
Country [106] 0 0
Spain
State/province [106] 0 0
Sevilla
Country [107] 0 0
Spain
State/province [107] 0 0
Vitoria
Country [108] 0 0
Spain
State/province [108] 0 0
Zaragoza
Country [109] 0 0
Thailand
State/province [109] 0 0
Bangkok
Country [110] 0 0
Thailand
State/province [110] 0 0
Khon Kaen
Country [111] 0 0
Vietnam
State/province [111] 0 0
Ho Chi Minh

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the efficacy and safety of a variable dose of
Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the
treatment of asthma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00242775
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Symbicort Medical Science Director, MD
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/ct2/show/NCT00242775