A 6-week, phase III, double-blind, randomized, multi-centre, parallel-group study evaluating the efficacy and safety of 2 actuations Symbicort® (budesonide/formoterol) pMDI 40/2.25 µg twice daily compared with 1 inhalation Symbicort Turbuhaler® 80/4.5 µg twice daily and 1 inhalation Pulmicort® (budesonide) Turbuhaler® 100 µg twice daily in adult and adolescent asthmatics

AstraZeneca AB0 sites600 target enrollmentAugust 7, 2007

Overview

No summary available.

Registry

who.int

Start Date

August 7, 2007

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•For inclusion in the study, patients must fulfill all of the following criteria at Visit 2:
•1\. Signed informed consent from the patient. For the under\-aged patients, signed informed consent is required from both the patient and the patient's parent/legal guardian.
•2\. Out\-patients of either sex, 12 years and above.
•3\. Asthma according to the American Thoracic Society (ATS) definition, clinically diagnosed at least 6 months prior to Visit 2\.
•4\. Pre\-bronchodilator FEV1 \= ?50% and \= ?90% of predicted normal.
•5\. Patients with reversible airway obstruction (from a reversibility test performed at Visit 2\), defined as an increase in FEV1 of \= 12% relative to baseline (for all patients), and for patients \=18 years \=200 mL after inhalation of in total 1 mg Bricanyl Turbuhaler..
•6\. Daily use of inhaled GCS (any brand) for \>3 months prior to Visit 2\.
•7\. During 30 days prior to Visit 2, the dose of inhaled GCS should have been constant and within the range of 200\-500 µg/day (any brand).
•8\. Ability to use pMDI, Turbuhaler, and peak flow meter correctly.
•9\. Able to read and write and use the electronic devices.

•1\. Use of oral, rectal or parenteral GCS within 30 days prior to Visit 2\.
•2\. Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to Visit 2\.
•3\. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.
•4\. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs at baseline visit, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.
•5\. Pregnancy, breast\-feeding or planned pregnancy during the study. Women and where applicable, girls of child\-bearing potential without acceptable contraceptive measures as judged by the investigator.
•6\. Known or suspected hypersensitivity to budesonide, formoterol, inhaled lactose, PVP K25, PEG 1000, HFA\-227\.
•7\. Present use of any ß\-blocker (including eye\-drops).
•8\. History of \= 10 pack\-years of smoking (i.e. equivalent of smoking 20 cigarettes per day for 10 years).
•9\. Planned donation of blood during the study.
•10\. Planned hospitalization during the study.