Asthma Clinical Trial
Official 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).
Verified date | January 2011 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2100 |
Est. completion date | May 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
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 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Research Site | Buenos Aires | |
Argentina | Research Site | Cordoba | |
Argentina | Research Site | Mar Del Plata | Buenos Aires |
Argentina | Research Site | Monte Grande | Buenos Aires |
Argentina | Research Site | San Miguel De Tucuman | Provincia De Tucuman |
Argentina | Research Site | Santa Fé | |
Argentina | Research Site | Tucuman | |
Australia | Research Site | Ashford | South Australia |
Australia | Research Site | Bankstown | New South Wales |
Australia | Research Site | Box Hill | Victoria |
Australia | Research Site | Bundaberg | Queensland |
Australia | Research Site | Carina Heights | Queensland |
Australia | Research Site | Mackay | Queensland |
Australia | Research Site | Malvern | Victoria |
Australia | Research Site | Nedlands | Western Australia |
Australia | Research Site | Prahran | Victoria |
Australia | Research Site | Rosebud | Victoria |
Australia | Research Site | Sydney | New South Wales |
Australia | Research Site | Toorak Gardens | South Australia |
Australia | Research Site | Westmead | New South Wales |
Australia | Research Site | Woodville South | South Australia |
Brazil | Research Site | Curitiba | |
Brazil | Research Site | Florianópolis | Santa Catarina |
Brazil | Research Site | Juiz de Fora | MG |
Brazil | Research Site | Recife | Pernambuco |
Brazil | Research Site | Rio de Janeiro | RJ |
Brazil | Research Site | Salvador | Bahia |
Brazil | Research Site | Sao Paulo | SP |
Brazil | Research Site | Sao Paulo | |
Brazil | Research Site | São Paulo | |
Canada | Research Site | Edmonton | Alberta |
Canada | Research Site | Hamilton | Ontario |
Canada | Research Site | London | Ontario |
Canada | Research Site | Mississauga | Ontario |
Canada | Research Site | Montreal | Quebec |
Canada | Research Site | Mount Pearl | Newfoundland and Labrador |
Canada | Research Site | North York | Ontario |
Canada | Research Site | Ottawa | Ontario |
Canada | Research Site | Quebec | |
Canada | Research Site | Saint-Leonard | Quebec |
Canada | Research Site | Saskatoon | Saskatchewan |
Canada | Research Site | Ste-Foy | Quebec |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Trois Rivieres | Quebec |
Canada | Research Site | Winnipeg | Manitoba |
China | Research Site | Beijing | |
China | Research Site | Guang Zhou | |
China | Research Site | Nan Jin | |
China | Research Site | Shanghai | |
China | Research Site | Shanxi | |
China | Research Site | Shenyang | |
France | Research Site | Angers | |
France | Research Site | Bernay | |
France | Research Site | Bethune | |
France | Research Site | Chamalieres | |
France | Research Site | Ferolles Attilly | |
France | Research Site | Grasse | |
France | Research Site | Henin Beaumont | |
France | Research Site | La Rochelle | |
France | Research Site | Laon | |
France | Research Site | Le Havre | |
France | Research Site | Lille | |
France | Research Site | Lorient | |
France | Research Site | MARSEILLE Cedex 06 | |
France | Research Site | Montereau Fault Yonne | |
France | Research Site | Montpellier | |
France | Research Site | Nantes | |
France | Research Site | NIMES Cedex 9 | |
France | Research Site | Paris | |
France | Research Site | Saint Denis | |
France | Research Site | Selestat | |
France | Research Site | St Laurent Du Var | |
France | Research Site | Toulouse Cedex 9 | |
France | Research Site | Villebon Sur Yvette | |
France | Research Site | Villejuif | |
Germany | Research Site | Bad Segeberg | Schleswig-Holstein |
Germany | Research Site | Berlin | |
Germany | Research Site | Bonn | |
Germany | Research Site | Cottbus | Brandenburg |
Germany | Research Site | Düsseldorf | |
Germany | Research Site | Düsseldorf | Nordrhein-Westfalen |
Germany | Research Site | Erfurt | |
Germany | Research Site | Frankfurt | Hessen |
Germany | Research Site | Geesthacht | |
Germany | Research Site | Großhansdorf | |
Germany | Research Site | Hagen | |
Germany | Research Site | Hamburg | |
Germany | Research Site | Jena-Maua | Thüringen |
Germany | Research Site | Kassel | |
Germany | Research Site | Koblenz | |
Germany | Research Site | Lübeck | |
Germany | Research Site | Marburg | |
Germany | Research Site | Münster | Nordrhein-Westfalen |
Germany | Research Site | Neuruppin | |
Germany | Research Site | Sonneberg | |
Germany | Research Site | Witten | |
India | Research Site | Coimbatore | |
India | Research Site | Hyderbad | |
India | Research Site | Mumbai | |
India | Research Site | Noida | |
Indonesia | Research Site | Bandung | |
Indonesia | Research Site | Jakarta | |
Indonesia | Research Site | Jakarta Timur | |
Indonesia | Research Site | Jakarta Timur | Jakarta - Indonesia |
Indonesia | Research Site | Semarang | Jawa Tengah |
Indonesia | Research Site | Solo | |
Malaysia | Research Site | Kuala Lumpur | |
Malaysia | Research Site | Seremban | |
Mexico | Research Site | Mexico | |
Mexico | Research Site | Villahermosa | Tabasco |
Mexico | Research Site | Zapopan | Jalisco |
Philippines | Research Site | Cebu City | |
Philippines | Research Site | Iloilo City | |
Philippines | Research Site | Quezon City | |
Singapore | Research Site | Singapore | |
South Africa | Research Site | Bellville | |
South Africa | Research Site | Bloemfontein | |
South Africa | Research Site | Bryanston | Gauteng |
South Africa | Research Site | Cape Town | |
South Africa | Research Site | Durban | |
South Africa | Research Site | Florida Park | Gauteng |
South Africa | Research Site | Hillcrest | Pretoria |
South Africa | Research Site | Johannesburg | |
South Africa | Research Site | Lenasia | Gauteng |
South Africa | Research Site | Linksfield | Gauteng |
South Africa | Research Site | Lyttelton Manor | |
South Africa | Research Site | Pretoria | |
South Africa | Research Site | Sandton | Gauteng |
South Africa | Research Site | Umkomaas | |
South Africa | Research Site | Witbank | Gauteng |
Spain | Research Site | Barcelona | |
Spain | Research Site | El Palmar | Murcia |
Spain | Research Site | Granada | |
Spain | Research Site | Jaén | |
Spain | Research Site | Madrid | |
Spain | Research Site | San Sebastián | Guipuzcoa |
Spain | Research Site | Santander | |
Spain | Research Site | Sevilla | |
Spain | Research Site | Vitoria | |
Spain | Research Site | Zaragoza | |
Thailand | Research Site | Bangkok | |
Thailand | Research Site | Khon Kaen | |
Vietnam | Research Site | Ho Chi Minh |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Indonesia, Malaysia, Mexico, Philippines, Singapore, South Africa, Spain, Thailand, Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first severe asthma exacerbation | |||
Secondary | Number of severe asthma exacerbations | |||
Secondary | Mild asthma exacerbations | |||
Secondary | FEV1 | |||
Secondary | Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries | |||
Secondary | Healthcare utilization | |||
Secondary | Safety (adverse events) | |||
Secondary | - all variables assessed over the 6 months treatment period |
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