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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00242775
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : January 24, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide/formoterol Turbuhaler Drug: Salmeterol/fluticasone Diskus Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 2100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : May 2005
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Intervention Details:
  • Drug: Budesonide/formoterol Turbuhaler
    Other Name: Symbicort
  • Drug: Salmeterol/fluticasone Diskus

Primary Outcome Measures :
  1. Time to first severe asthma exacerbation

Secondary Outcome Measures :
  1. Number of severe asthma exacerbations
  2. Mild asthma exacerbations
  3. FEV1
  4. Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries
  5. Healthcare utilization
  6. Safety (adverse events)
  7. - all variables assessed over the 6 months treatment period

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242775

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Sponsors and Collaborators
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Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00242775    
Other Study ID Numbers: D5890C00002
EurodraCT No. 2004-004905-11
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents