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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: October 20, 2005
Last updated: January 21, 2011
Last verified: January 2011

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 Intervention Phase
Drug: Budesonide/formoterol Turbuhaler
Drug: Salmeterol/fluticasone Diskus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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).

Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 2100
Study Start Date: May 2005
Study Completion Date: May 2006
Intervention Details:
    Drug: Budesonide/formoterol Turbuhaler
    Other Name: Symbicort
    Drug: Salmeterol/fluticasone Diskus

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00242775

  Show 143 Study Locations
Sponsors and Collaborators
Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00242775     History of Changes
Other Study ID Numbers: D5890C00002, EurodraCT No. 2004-004905-11, AHEAD
Study First Received: October 20, 2005
Last Updated: January 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses processed this record on March 26, 2015