An Open, Phase III, Multicentre, 52-week Study, Evaluating the Safety and Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma

AstraZeneca1 site in 1 country120 target enrollmentNovember 2005

Overview

Brief Summary

This study is to confirm the safety of Symbicort® Turbuhaler® 160/4.5 µg 1, 2 or 4 inhalation b.i.d. over a 52 week treatment period in asthmatic patients who are being treated with IGCS and long acting β2-agonist (LABA) and/or other anti-asthmatic drugs.

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

June 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Diagnosis of asthma with a documented history of at least 6 months duration prior to Visit 1
•Prescribed daily use of an IGCS for ≥12 weeks prior to Visit 1
•Prescribed daily use of at least one of the following:
•Theophylline, long acting β2-agonist (LABA), other anti-asthmatic drugs (leucotrine antagonists, inhaled anti-cholinergics, Th2 cytokine inhibitor) for at least 4 weeks prior to Visit 1 at a constant dose

Exclusion Criteria

•Any significant disease or disorder that may jeopardize the safety of the patient
•Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1
•Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1

Outcomes

Primary Outcomes

Safety: Adverse events (nature, incidence and severity) Haematology, clinical chemistry, morning plasma cortisol, urinalysis, and ACTH challenge test 12-lead ECGs, blood pressure, pulse rate

Secondary Outcomes

Forced expiratory volume in one second (FEV1)
Patient reported outcomes regarding disease status (incl. PEF), collected via diaries
- all variables assessed over the 52 week treatment period