Safety & Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Budesonide/Formoterol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00255255

D5890C00009

Details and patient eligibility

About

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.

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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