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

January 21, 2011 updated by: AstraZeneca

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

2100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Cordoba, Argentina
        • Research Site
      • Santa Fé, Argentina
        • Research Site
      • Tucuman, Argentina
        • Research Site
    • Buenos Aires
      • Mar Del Plata, Buenos Aires, Argentina
        • Research Site
      • Monte Grande, Buenos Aires, Argentina
        • Research Site
    • Provincia De Tucuman
      • San Miguel De Tucuman, Provincia De Tucuman, Argentina
        • Research Site
  • Australia
    • New South Wales
      • Bankstown, New South Wales, Australia
        • Research Site
      • Sydney, New South Wales, Australia
        • Research Site
      • Westmead, New South Wales, Australia
        • Research Site
    • Queensland
      • Bundaberg, Queensland, Australia
        • Research Site
      • Carina Heights, Queensland, Australia
        • Research Site
      • Mackay, Queensland, Australia
        • Research Site
    • South Australia
      • Ashford, South Australia, Australia
        • Research Site
      • Toorak Gardens, South Australia, Australia
        • Research Site
      • Woodville South, South Australia, Australia
        • Research Site
    • Victoria
      • Box Hill, Victoria, Australia
        • Research Site
      • Malvern, Victoria, Australia
        • Research Site
      • Prahran, Victoria, Australia
        • Research Site
      • Rosebud, Victoria, Australia
        • Research Site
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Research Site
  • Brazil
      • Curitiba, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
      • São Paulo, Brazil
        • Research Site
    • Bahia
      • Salvador, Bahia, Brazil
        • Research Site
    • MG
      • Juiz de Fora, MG, Brazil
        • Research Site
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Research Site
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Research Site
    • SP
      • Sao Paulo, SP, Brazil
        • Research Site
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil
        • Research Site
  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada
        • Research Site
    • Ontario
      • 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
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
      • Saint-Leonard, Quebec, Canada
        • Research Site
      • Ste-Foy, Quebec, Canada
        • Research Site
      • Trois Rivieres, Quebec, Canada
        • Research Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Research Site
  • China
      • 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
  • France
      • 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
      • NIMES Cedex 9, France
        • Research Site
      • Nantes, 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
  • Germany
      • Berlin, Germany
        • 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
      • Hamburg, 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
    • Brandenburg
      • Cottbus, Brandenburg, Germany
        • Research Site
    • Hessen
      • Frankfurt, Hessen, Germany
        • Research Site
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany
        • Research Site
      • Münster, Nordrhein-Westfalen, Germany
        • Research Site
    • Schleswig-Holstein
      • Bad Segeberg, Schleswig-Holstein, Germany
        • Research Site
    • Thüringen
      • Jena-Maua, Thüringen, Germany
        • Research Site
  • India
      • Coimbatore, India
        • Research Site
      • Hyderbad, India
        • Research Site
      • Mumbai, India
        • Research Site
      • Noida, India
        • Research Site
  • Indonesia
      • Bandung, Indonesia
        • Research Site
      • Jakarta, Indonesia
        • Research Site
      • Jakarta Timur, Indonesia
        • Research Site
      • Solo, Indonesia
        • Research Site
    • Jakarta - Indonesia
      • Jakarta Timur, Jakarta - Indonesia, Indonesia
        • Research Site
    • Jawa Tengah
      • Semarang, Jawa Tengah, Indonesia
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Research Site
      • Seremban, Malaysia
        • Research Site
  • Mexico
      • Mexico, Mexico
        • Research Site
    • Jalisco
      • Zapopan, Jalisco, Mexico
        • Research Site
    • Tabasco
      • Villahermosa, Tabasco, Mexico
        • Research Site
  • Philippines
      • Cebu City, Philippines
        • Research Site
      • Iloilo City, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Singapore
      • Singapore, Singapore
        • Research Site
  • South Africa
      • Bellville, South Africa
        • 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
      • Pretoria, South Africa
        • Research Site
      • Umkomaas, South Africa
        • Research Site
    • Gauteng
      • 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
    • Pretoria
      • Hillcrest, Pretoria, South Africa
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Granada, Spain
        • Research Site
      • Jaén, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Santander, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Vitoria, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
    • Guipuzcoa
      • San Sebastián, Guipuzcoa, Spain
        • Research Site
    • Murcia
      • El Palmar, Murcia, Spain
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Khon Kaen, Thailand
        • Research Site
  • Vietnam
      • Ho Chi Minh, Vietnam
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to first severe asthma exacerbation

Secondary Outcome Measures

Outcome Measure
FEV1
Number of severe asthma exacerbations
Mild asthma exacerbations
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

October 20, 2005

First Submitted That Met QC Criteria

October 20, 2005

First Posted (Estimate)

October 21, 2005

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5890C00002
  • EurodraCT No. 2004-004905-11
  • AHEAD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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