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

NCT ID: NCT00242775

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Budesonide/formoterol Turbuhaler

Intervention Type DRUG

Salmeterol/fluticasone Diskus

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Symbicort Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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, City state of 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

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Countries

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Argentina Australia Brazil Canada China France Germany India Indonesia Malaysia Mexico Philippines Singapore South Africa Spain Thailand Vietnam

References

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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.

Reference Type DERIVED
PMID: 22932169 (View on PubMed)

Bousquet 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.

Reference Type DERIVED
PMID: 17905575 (View on PubMed)

Other Identifiers

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EurodraCT No. 2004-004905-11

Identifier Type: -

Identifier Source: secondary_id

AHEAD

Identifier Type: -

Identifier Source: secondary_id

D5890C00002

Identifier Type: -

Identifier Source: org_study_id

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