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

AstraZeneca AB0 sites2,309 target enrollmentJanuary 25, 2006

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: This is a Phase IIIB study to be performed in adult and adolescent asthmatic patients.
Sponsor: AstraZeneca AB
Enrollment: 2309
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

January 25, 2006

End Date

October 27, 2006

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•For inclusion in the study run\-in period, patients must fulfill all of the following criteria
•at Visit 1:
•1\. Provision of informed consent. The signed and dated informed consent must
•have been obtained before conducting any study\-related procedures, including withdrawal of concomitant medication (consent can be obtained at an information visit or at Visit 1\). For patients under\-age, signed informed consent from both the
•patient and the patient’s parent/legal guardian is required.
•2\. Outpatients of either sex, \=12 years of age.
•3\. Minimum of 6 months’ documented history of asthma according to the American Thoracic Society definition (ATS 1987\).
•4\. Pre\-bronchodilatory FEV1 \=50% of predicted normal values.
•5\. Reversible airway obstruction (according to reversibility test performed at Visit 1\), defined as an increase in FEV1 \=12% relative to baseline (for all patients) and for patients \=18 years \=200 mL after inhalation of in total 1 mg Bricanyl Turbuhaler.
•6\. Prescribed daily use of inhaled GCS for \=3 months prior to Visit 1\.

•1\. Known or suspected hypersensitivity to active substance or lactose monohydrate.
•2\. Respiratory infection affecting the asthma, as judged by the investigator, within
•30 days prior to Visit 1\.
•3\. Intake of oral, rectal, or parenteral GCS within 30 days prior to Visit 1\.
•4\. Use of any ß\-blocking agent, including eye\-drops.
•5\. A history of smoking \=10 pack\-years (one pack\-year \= one pack (20 cigarettes)
•per day for one year or equivalent).
•6\. Pregnancy, breast\-feeding, or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
•7\. Any significant disease or disorder (eg, cardiovascular, pulmonary other than
•asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine,