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Comparison of the Efficacy/Safety of ‘Symbicort Turbuhaler’,’Seretide Diskus’ 50/500 micrograms & Terbutaline ‘Turbuhaler’ 0.4 Mg

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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.

Official Title

Efficacy and Safety of Symbicort Turbuhaler 160/4.5 micrograms/Inhalation, Two Inhalations Twice Daily Plus as-Needed Compared With Seretide Diskus 50/500 micrograms/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).

Conditions

Asthma

Study Type

Interventional

Study Design

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

Further Details

Primary Outcome Measures:

  • Time to first severe asthma exacerbation

Secondary Outcome Measures:

  • 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)

Study Start

May 2005; Study completion: June 2006

Eligibility & Criteria

  • Ages Eligible for Study: 12 Years and aboveGenders Eligible for Study: Both

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

Total Enrolment

2100

Contact Details

New South Wales Research Site, Bankstown, New South Wales, Australia Research Site, Sydney, New South Wales, Australia Research Site, Westmead, New South Wales, Australia Queensland Research Site, Bundaberg, Queensland, Australia Research Site, Carina Heights, Queensland, Australia Research Site, Mackay, Queensland, Australia South Australia Research Site, ASHFORD, South Australia, Australia Research Site, Toorak Gardens, South Australia, Australia Research Site, Woodville South, South Australia, Australia Victoria Research Site, Box Hill, Victoria, Australia Research Site, Malvern, Victoria, Australia Research Site, Prahran, Victoria, Australia Research Site, Rosebud, Victoria, Australia Western Australia Research Site, Nedlands, Western Australia, Australia AstraZeneca AustraliaContact AstraZeneca International for more information about this trial (Study #: D5890C00002)

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Dates

Posted On: 1 January, 2013
Modified On: 16 September, 2014

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