Clinical trial NCT00242775: Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mg
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-21
Enrollment: 2100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Time to first severe asthma exacerbation
Secondary outcomes:
measure: Number of severe asthma exacerbations
measure: Mild asthma exacerbations
measure: FEV1
measure: Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries
measure: Healthcare utilization
measure: Safety (adverse events)
measure: - all variables assessed over the 6 months treatment period
Other outcomes:
Locations:
city: Mar Del Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Monte Grande
country: Argentina
facility: Research Site
state: Buenos Aires
city: San Miguel De Tucuman
country: Argentina
facility: Research Site
state: Provincia De Tucuman
city: Buenos Aires
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: Santa Fé
country: Argentina
facility: Research Site
city: Tucuman
country: Argentina
facility: Research Site
city: Bankstown
country: Australia
facility: Research Site
state: New South Wales
city: Sydney
country: Australia
facility: Research Site
state: New South Wales
city: Westmead
country: Australia
facility: Research Site
state: New South Wales
city: Bundaberg
country: Australia
facility: Research Site
state: Queensland
city: Carina Heights
country: Australia
facility: Research Site
state: Queensland
city: Mackay
country: Australia
facility: Research Site
state: Queensland
city: Ashford
country: Australia
facility: Research Site
state: South Australia
city: Toorak Gardens
country: Australia
facility: Research Site
state: South Australia
city: Woodville South
country: Australia
facility: Research Site
state: South Australia
city: Box Hill
country: Australia
facility: Research Site
state: Victoria
city: Malvern
country: Australia
facility: Research Site
state: Victoria
city: Prahran
country: Australia
facility: Research Site
state: Victoria
city: Rosebud
country: Australia
facility: Research Site
state: Victoria
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Salvador
country: Brazil
facility: Research Site
state: Bahia
city: Juiz de Fora
country: Brazil
facility: Research Site
state: MG
city: Recife
country: Brazil
facility: Research Site
state: Pernambuco
city: Rio de Janeiro
country: Brazil
facility: Research Site
state: RJ
city: Florianópolis
country: Brazil
facility: Research Site
state: Santa Catarina
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Curitiba
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Mount Pearl
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: North York
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Saint-Leonard
country: Canada
facility: Research Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Research Site
state: Quebec
city: Trois Rivieres
country: Canada
facility: Research Site
state: Quebec
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Guang Zhou
country: China
facility: Research Site
city: Nan Jin
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanxi
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Bernay
country: France
facility: Research Site
city: Bethune
country: France
facility: Research Site
city: Chamalieres
country: France
facility: Research Site
city: Ferolles Attilly
country: France
facility: Research Site
city: Grasse
country: France
facility: Research Site
city: Henin Beaumont
country: France
facility: Research Site
city: La Rochelle
country: France
facility: Research Site
city: Laon
country: France
facility: Research Site
city: Le Havre
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Lorient
country: France
facility: Research Site
city: MARSEILLE Cedex 06
country: France
facility: Research Site
city: Montereau Fault Yonne
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: NIMES Cedex 9
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Saint Denis
country: France
facility: Research Site
city: Selestat
country: France
facility: Research Site
city: St Laurent Du Var
country: France
facility: Research Site
city: Toulouse Cedex 9
country: France
facility: Research Site
city: Villebon Sur Yvette
country: France
facility: Research Site
city: Villejuif
country: France
facility: Research Site
city: Cottbus
country: Germany
facility: Research Site
state: Brandenburg
city: Frankfurt
country: Germany
facility: Research Site
state: Hessen
city: Düsseldorf
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Bad Segeberg
country: Germany
facility: Research Site
state: Schleswig-Holstein
city: Jena-Maua
country: Germany
facility: Research Site
state: Thüringen
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Geesthacht
country: Germany
facility: Research Site
city: Großhansdorf
country: Germany
facility: Research Site
city: Hagen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Koblenz
country: Germany
facility: Research Site
city: Lübeck
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Neuruppin
country: Germany
facility: Research Site
city: Sonneberg
country: Germany
facility: Research Site
city: Witten
country: Germany
facility: Research Site
city: Coimbatore
country: India
facility: Research Site
city: Hyderbad
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Noida
country: India
facility: Research Site
city: Jakarta Timur
country: Indonesia
facility: Research Site
state: Jakarta - Indonesia
city: Semarang
country: Indonesia
facility: Research Site
state: Jawa Tengah
city: Bandung
country: Indonesia
facility: Research Site
city: Jakarta Timur
country: Indonesia
facility: Research Site
city: Jakarta
country: Indonesia
facility: Research Site
city: Solo
country: Indonesia
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Seremban
country: Malaysia
facility: Research Site
city: Zapopan
country: Mexico
facility: Research Site
state: Jalisco
city: Villahermosa
country: Mexico
facility: Research Site
state: Tabasco
city: Mexico
country: Mexico
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Bryanston
country: South Africa
facility: Research Site
state: Gauteng
city: Florida Park
country: South Africa
facility: Research Site
state: Gauteng
city: Lenasia
country: South Africa
facility: Research Site
state: Gauteng
city: Linksfield
country: South Africa
facility: Research Site
state: Gauteng
city: Sandton
country: South Africa
facility: Research Site
state: Gauteng
city: Witbank
country: South Africa
facility: Research Site
state: Gauteng
city: Hillcrest
country: South Africa
facility: Research Site
state: Pretoria
city: Bellville
country: South Africa
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Lyttelton Manor
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Umkomaas
country: South Africa
facility: Research Site
city: San Sebastián
country: Spain
facility: Research Site
state: Guipuzcoa
city: El Palmar
country: Spain
facility: Research Site
state: Murcia
city: Barcelona
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Jaén
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Vitoria
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Khon Kaen
country: Thailand
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Symbicort Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.