Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients

Condition(s) targeted: Asthma

Intervention: Budesonide/Formoterol (Drug); Budesonide (Drug); Theophylline (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

The primary objective of this study is to confirm the efficacy (superiority) of Symbicort® Turbuhaler® 160/4. 5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg twice daily + Theolong® tablet 200 mg twice daily.

Official title: An 8-Week, Randomised, Double Blind, Parallel-Group, Multi-Centre, Phase III Study Comparing the Efficacy and Safety of Symbicort® Turbuhaler® 160/4.5 µg Twice Daily and Pulmicort® Turbuhaler® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Patients With Asthma

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Morning peak expiratory flow (mPEF)

Secondary outcome:

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

Forced expiratory volume in one second (FEV1)

Safety:

Adverse events (nature, incidence and severity)

Haematology, clinical chemistry and urinalysis

12-lead ECGs, blood pressure, pulse rate

- all variables assessed over the 8 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. The dose of IGCS must

be 400 to 800 µg/day of Pulmicort® Turbuhaler® or corresponding dose of IGCS. The prescribed dose of IGCS should be constant for at least 4 weeks prior to Visit 1

- Prescribed daily use of sustained release theophylline for at least 8 weeks prior to

Visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 µg/mL) during 8 weeks prior to Visit 1. The prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to Visit 1

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

Additional inclusion and exclusion criteria will be evaluated by the Investigator

Research Site, Tochigi, Japan

Research Site, Gifu, Japan

Research Site, Hiroshima, Japan

Research Site, Kagoshima, Japan

Research Site, Kyoto, Japan

Research Site, Oita, Japan

Research Site, Okayama, Japan

Research Site, Osaka, Japan

Research Site, Toyama, Japan

Research Site, Komaki, Aichi, Japan

Research Site, Seto, Aichi, Japan

Research Site, Asahi, Chiba, Japan

Research Site, Noda, Chiba, Japan

Research Site, Touon, Ehime, Japan

Research Site, Mizumaki, Fukuoka, Japan

Research Site, Isesaki, Gunma, Japan

Research Site, Maebashi, Gunma, Japan

Research Site, Ora, Gunma, Japan

Research Site, Ota, Gunma, Japan

Research Site, Chitose, Hokkaido, Japan

Research Site, Kitahiroshima, Hokkaido, Japan

Research Site, Obihiro, Hokkaido, Japan

Research Site, Sapporo, Hokkaido, Japan

Research Site, Tomakomai, Hokkaido, Japan

Research Site, Morioka, Iwate, Japan

Research Site, Takamatsu, Kagawa, Japan

Research Site, Sendai, Miyagi, Japan

Research Site, Beppu, Ohita, Japan

Research Site, Tsukubo, Okayama, Japan

Research Site, Kishiwada, Osaka, Japan

Research Site, Oskasayama, Osaka, Japan

Research Site, Takatsuiki, Osaka, Japan

Research Site, Koshigaya, Saitama, Japan

Research Site, Minamisaitama, Saitama, Japan

Research Site, Arakawa, Tokyo, Japan

Research Site, Chiyoda, Tokyo, Japan

Research Site, Kodaira, Tokyo, Japan

Research Site, Nakano-ku, Tokyo, Japan

Research Site, Ota-ku, Tokyo, Japan

Research Site, Shinagawa-ku, Tokyo, Japan

Research Site, Sumida, Tokyo, Japan

Research Site, Itabashi, Tokyo, Japan

Research Site, Ube, Yamaguchi, Japan

Starting date: November 2005
Ending date: December 2006
Last updated: January 11, 2008