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

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242775
• Other study ID #: D5890C00002
• Secondary ID: EurodraCT No. 20
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2005
• Last updated: January 21, 2011
• Start date: May 2005
• Est. completion date: May 2006

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2100
• Est. completion date: May 2006
• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide/formoterol Turbuhaler

• Salmeterol/fluticasone Diskus

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

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

Outcome

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