Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mg
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).
3 other identifiers
interventional
2,100
17 countries
143
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started May 2005
Shorter than P25 for phase_3 asthma
143 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 20, 2005
CompletedFirst Posted
Study publicly available on registry
October 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedJanuary 24, 2011
January 1, 2011
October 20, 2005
January 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first severe asthma exacerbation
Secondary Outcomes (7)
Number of severe asthma exacerbations
Mild asthma exacerbations
FEV1
Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries
Healthcare utilization
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (143)
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Mar del Plata, Buenos Aires, Argentina
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Monte Grande, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Santa Fé, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Buenos Aires, Argentina
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San Miguel de Tucumán, Argentina
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Bankstown, New South Wales, Australia
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Sydney, New South Wales, Australia
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Westmead, New South Wales, Australia
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Bundaberg, Queensland, Australia
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Carina Heights, Queensland, Australia
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Mackay, Queensland, Australia
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Ashford, South Australia, Australia
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Toorak Gardens, South Australia, Australia
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Woodville South, South Australia, Australia
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Box Hill, Victoria, Australia
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Malvern, Victoria, Australia
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Prahran, Victoria, Australia
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Rosebud, Victoria, Australia
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Nedlands, Western Australia, Australia
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Salvador, Estado de Bahia, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Recife, Pernambuco, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Florianópolis, Santa Catarina, Brazil
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São Paulo, São Paulo, Brazil
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Curitiba, Brazil
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São Paulo, Brazil
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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North York, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Léonard, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Beijing, China
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Guangzhou, China
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Nanjin, China
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Shanghai, China
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Shanxi, China
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Shenyang, China
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Angers, France
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Bernay, France
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Béthune, France
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Chamalières, France
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Férolles-Attilly, France
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Grasse, France
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Hénin-Beaumont, France
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La Rochelle, France
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Laon, France
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Le Havre, France
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Lille, France
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Lorient, France
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Marseille, France
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Montereau-Fault-Yonne, France
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Montpellier, France
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Nantes, France
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Nîmes, France
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Paris, France
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Saint-Denis, France
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Saint-Laurent-du-Var, France
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Sélestat, France
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Toulouse, France
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Villebon-sur-Yvette, France
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Villejuif, France
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Cottbus, Brandenburg, Germany
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Hamburg, Hamburg, Germany
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Frankfurt am Main, Hesse, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Münster, North Rhine-Westphalia, Germany
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Bad Segeberg, Schleswig-Holstein, Germany
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Berlin, State of Berlin, Germany
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Jena-Maua, Thuringia, Germany
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Bonn, Germany
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Düsseldorf, Germany
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Erfurt, Germany
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Geesthacht, Germany
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Großhansdorf, Germany
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Hagen, Germany
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Kassel, Germany
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Koblenz, Germany
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Lübeck, Germany
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Marburg, Germany
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Neuruppin, Germany
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Sonneberg, Germany
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Witten, Germany
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Coimbatore, India
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Hyderbad, India
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Mumbai, India
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Noida, India
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Semarang, Central Java, Indonesia
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Jakarta Timur, Jakarta - Indonesia, Indonesia
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Bandung, Indonesia
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Jakarta, Indonesia
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Jakarta Timur, Indonesia
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Solo, Indonesia
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Kuala Lumpur, Malaysia
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Seremban, Malaysia
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Zapopan, Jalisco, Mexico
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Villahermosa, Tabasco, Mexico
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México, Mexico
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Cebu City, Philippines
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Iloilo City, Philippines
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Quezon City, Philippines
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Singapore, Singapore
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Bryanston, Gauteng, South Africa
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Florida Park, Gauteng, South Africa
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Lenasia, Gauteng, South Africa
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Linksfield, Gauteng, South Africa
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Sandton, Gauteng, South Africa
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Witbank, Gauteng, South Africa
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Hillcrest, Pretoria, South Africa
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Bellville, South Africa
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Bloemfontein, South Africa
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Cape Town, South Africa
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Durban, South Africa
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eMkhomazi, South Africa
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Johannesburg, South Africa
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Lyttelton Manor, South Africa
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Pretoria, South Africa
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Barcelona, Barcelona, Spain
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Santander, Cantabria, Spain
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Granada, Granada, Spain
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San Sebastián, Guipuzcoa, Spain
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Jaén, Jaén, Spain
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Madrid, Madrid, Spain
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El Palmar, Murcia, Spain
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Seville, Sevilla, Spain
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Vitoria-Gasteiz, Vitoria, Spain
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Zaragoza, Zaragoza, Spain
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Seville, Spain
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Bangkok, Thailand
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Khon Kaen, Thailand
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Ho Chi Minh City, Vietnam
Related Publications (2)
Lin JT, Chen P, Zhou X, Sun TY, Xie CM, Xiu QY, Yao WZ, Yang L, Yin KS, Zhang YM. Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma. Chin Med J (Engl). 2012 Sep;125(17):2994-3001.
PMID: 22932169DERIVEDBousquet J, Boulet LP, Peters MJ, Magnussen H, Quiralte J, Martinez-Aguilar NE, Carlsheimer A. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med. 2007 Dec;101(12):2437-46. doi: 10.1016/j.rmed.2007.07.014. Epub 2007 Oct 1.
PMID: 17905575DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Symbicort Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 20, 2005
First Posted
October 21, 2005
Study Start
May 1, 2005
Study Completion
May 1, 2006
Last Updated
January 24, 2011
Record last verified: 2011-01