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

Condition(s) targeted: Asthma

Intervention: Budesonide/Formoterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Symbicort Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 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 outcome:

Patient reported outcomes regarding disease status (incl. PEF), collected via diaries

Forced expiratory volume in one second (FEV1)

- all variables assessed over the 52 week treatment period

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Research Site, Gifu, Japan

Research Site, Hiroshima, Japan

Research Site, Kagoshima, Japan

Research Site, Kochi, Japan

Research Site, Komaki, Aichi, Japan

Research Site, Seto, Aichi, Japan

Research Site, Ora, Gunma, Japan

Research Site, Sapporo, Hokkaido, Japan

Research Site, Tomakomai, Hokkaido, Japan

Research Site, Morioka, Iwate, Japan

Research Site, Takamatsu, Kagawa, Japan

Research Site, Beppu, Ohita, Japan

Research Site, Tsukubo-gun, Okayama, Japan

Research Site, Kishiwada, Osaka, Japan

Research Site, Takatsuki, Osaka, Japan

Research Site, Ota-ku, Tokyo, Japan

Research Site, Shinjuku-ku, Tokyo, Japan

Research Site, Ube, Yamaguchi, Japan

Starting date: November 2005
Ending date: January 2008
Last updated: January 11, 2008