Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 Mg

Condition(s) targeted: Asthma

Intervention: Budesonide/formoterol Turbuhaler (Drug); Salmeterol/fluticasone Diskus (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Symbicort Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

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).

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time to first severe asthma exacerbation

Secondary outcome:

Number of severe asthma exacerbations

Mild asthma exacerbations

FEV1

Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries

Healthcare utilization

Safety (adverse events)

- all variables assessed over the 6 months treatment period

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Research Site, Buenos Aires, Argentina

Research Site, Tucuman, Argentina

Research Site, Cordoba, Argentina

Research Site, Santa Fé, Argentina

Research Site, Curitiba, Brazil

Research Site, São Paulo, Brazil

Research Site, Sao Paulo, Brazil

Research Site, Quebec, Canada

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, China

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, LAON, France

Research Site, LA ROCHELLE, 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, France

Research Site, Bonn, Germany

Research Site, Düsseldorf, Germany

Research Site, Erfurt, Germany

Research Site, Geesthacht, Germany

Research Site, Großhansdorf, Germany

Research Site, Hagen, Germany

Research Site, Kassel, Germany

Research Site, Koblenz, Germany

Research Site, Lübeck, Germany

Research Site, Marburg, Germany

Research Site, Neuruppin, Germany

Research Site, Sonneberg, Germany

Research Site, Witten, Germany

Research Site, Berlin, Germany

Research Site, Hamburg, Germany

Research Site, Coimbatore, India

Research Site, Hyderbad, India

Research Site, Mumbai, India

Research Site, Noida, India

Research Site, Bandung, Indonesia

Research Site, Jakarta, Indonesia

Research Site, Jakarta Timur, Indonesia

Research Site, Solo, Indonesia

Research Site, Kuala Lumpur, Malaysia

Research Site, Seremban, Malaysia

Research Site, MEXICO, Mexico

Research Site, Cebu City, Philippines

Research Site, Iloilo City, Philippines

Research Site, Quezon City, Philippines

Research Site, Singapore, Singapore

Research Site, Bloemfontein, South Africa

Research Site, Cape Town, South Africa

Research Site, Durban, South Africa

Research Site, Johannesburg, South Africa

Research Site, Lyttelton Manor, South Africa

Research Site, Umkomaas, South Africa

Research Site, Bellville, South Africa

Research Site, Pretoria, South Africa

Research Site, Sevilla, Spain

Research Site, Barcelona, Spain

Research Site, Granada, Spain

Research Site, Jaén, Spain

Research Site, Madrid, Spain

Research Site, Santander, Spain

Research Site, Vitoria, Spain

Research Site, Zaragoza, Spain

Research Site, Bangkok, Thailand

Research Site, Khon Kaen, Thailand

Research Site, Ho Chi Minh, Vietnam

Research Site, Edmonton, Alberta, Canada

Research Site, Salvador, Bahia, Brazil

Research Site, Cottbus, Brandenburg, Germany

Research Site, Monte Grande, Buenos Aires, Argentina

Research Site, Mar Del Plata, Buenos Aires, Argentina

Research Site, Bryanston, Gauteng, South Africa

Research Site, Florida Park, Gauteng, South Africa

Research Site, Lenasia, Gauteng, South Africa

Research Site, Linksfield, Gauteng, South Africa

Research Site, Sandton, Gauteng, South Africa

Research Site, Witbank, Gauteng, South Africa

Research Site, San Sebastián, Guipuzcoa, Spain

Research Site, Frankfurt, Hessen, Germany

Research Site, Jakarta Timur, Jakarta - Indonesia, Indonesia

Research Site, Zapopan, Jalisco, Mexico

Research Site, Semarang, Jawa Tengah, Indonesia

Research Site, Winnipeg, Manitoba, Canada

Research Site, El Palmar, Murcia, Spain

Research Site, Bankstown, New South Wales, Australia

Research Site, Sydney, New South Wales, Australia

Research Site, Westmead, New South Wales, Australia

Research Site, Mount Pearl, Newfoundland and Labrador, Canada

Research Site, Düsseldorf, Nordrhein-Westfalen, Germany

Research Site, Münster, Nordrhein-Westfalen, Germany

Research Site, Hamilton, Ontario, Canada

Research Site, London, Ontario, Canada

Research Site, Mississauga, Ontario, Canada

Research Site, North York, Ontario, Canada

Research Site, Ottawa, Ontario, Canada

Research Site, Toronto, Ontario, Canada

Research Site, Recife, Pernambuco, Brazil

Research Site, Hillcrest, Pretoria, South Africa

Research Site, San Miguel De Tucuman, Provincia De Tucuman, Argentina

Research Site, Montreal, Quebec, Canada

Research Site, Saint-Leonard, Quebec, Canada

Research Site, Ste-Foy, Quebec, Canada

Research Site, Trois Rivieres, Quebec, Canada

Research Site, Bundaberg, Queensland, Australia

Research Site, Carina Heights, Queensland, Australia

Research Site, Mackay, Queensland, Australia

Research Site, Rio de Janeiro, RJ, Brazil

Research Site, Sao Paulo, SP, Brazil

Research Site, Florianópolis, Santa Catarina, Brazil

Research Site, Saskatoon, Saskatchewan, Canada

Research Site, Bad Segeberg, Schleswig-Holstein, Germany

Research Site, ASHFORD, South Australia, Australia

Research Site, Toorak Gardens, South Australia, Australia

Research Site, Woodville South, South Australia, Australia

Research Site, Villahermosa, Tabasco, Mexico

Research Site, Jena-Maua, Thüringen, Germany

Research Site, Box Hill, Victoria, Australia

Research Site, Malvern, Victoria, Australia

Research Site, Prahran, Victoria, Australia

Research Site, Rosebud, Victoria, Australia

Research Site, Nedlands, Western Australia, Australia

Research Site, Juiz de Fora, mg, Brazil

Starting date: May 2005
Ending date: June 2006
Last updated: June 23, 2006