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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Asthma

Treatments

Drug: Budesonide/formoterol Turbuhaler
Drug: Salmeterol/fluticasone Diskus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00242775
EurodraCT No. 2004-004905-11
AHEAD
D5890C00002

Details and patient eligibility

About

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.

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

143

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Data sourced from clinicaltrials.gov

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