Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Budesonide, Formoterol Fumarate Drug Combination; Terbutaline

Criteria

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures

• A minimum of 6 months documented history of asthma according to the JGL2006/GINA2006 definition

• FEV1> 70% of predicted normal value pre-bronchodilator

Exclusion Criteria:

• Having a known or suspected allergy to study therapy (active drugs or additive)

• Having a known clinical history of hypertension, relevant arrhythmias or other heart disease, eg, ischemic heart disease, cardiomyopathy, valvular heart disease, or heart failure

• Having been treated with oral, parenteral or rectal glucocorticoids within 4 weeks, or with depot parenteral glucocorticoids within 3 months

• Respiratory infection significantly affecting the asthma, as judged by the investigator within 4 weeks