Clinical trial NCT00252785: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 340
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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. 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

Primary outcomes:
measure: Morning peak expiratory flow (mPEF)
Secondary outcomes:
measure: Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries
measure: Forced expiratory volume in one second (FEV1)
measure: Safety:
measure: Adverse events (nature, incidence and severity)
measure: Haematology, clinical chemistry and urinalysis
measure: 12-lead ECGs, blood pressure, pulse rate
measure: - all variables assessed over the 8 week treatment period
Other outcomes:
Locations:
city: Komaki
country: Japan
facility: Research Site
state: Aichi
city: Seto
country: Japan
facility: Research Site
state: Aichi
city: Asahi
country: Japan
facility: Research Site
state: Chiba
city: Noda
country: Japan
facility: Research Site
state: Chiba
city: Touon
country: Japan
facility: Research Site
state: Ehime
city: Mizumaki
country: Japan
facility: Research Site
state: Fukuoka
city: Isesaki
country: Japan
facility: Research Site
state: Gunma
city: Maebashi
country: Japan
facility: Research Site
state: Gunma
city: Ora
country: Japan
facility: Research Site
state: Gunma
city: Ota
country: Japan
facility: Research Site
state: Gunma
city: Chitose
country: Japan
facility: Research Site
state: Hokkaido
city: Kitahiroshima
country: Japan
facility: Research Site
state: Hokkaido
city: Obihiro
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Tomakomai
country: Japan
facility: Research Site
state: Hokkaido
city: Morioka
country: Japan
facility: Research Site
state: Iwate
city: Takamatsu
country: Japan
facility: Research Site
state: Kagawa
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Beppu
country: Japan
facility: Research Site
state: Ohita
city: Tsukubo
country: Japan
facility: Research Site
state: Okayama
city: Kishiwada
country: Japan
facility: Research Site
state: Osaka
city: Oskasayama
country: Japan
facility: Research Site
state: Osaka
city: Takatsuiki
country: Japan
facility: Research Site
state: Osaka
city: Koshigaya
country: Japan
facility: Research Site
state: Saitama
city: Minamisaitama
country: Japan
facility: Research Site
state: Saitama
city: Arakawa
country: Japan
facility: Research Site
state: Tokyo
city: Chiyoda
country: Japan
facility: Research Site
state: Tokyo
city: Itabashi
country: Japan
facility: Research Site
state: Tokyo
city: Kodaira
country: Japan
facility: Research Site
state: Tokyo
city: Nakano-ku
country: Japan
facility: Research Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Sumida
country: Japan
facility: Research Site
state: Tokyo
city: Ube
country: Japan
facility: Research Site
state: Yamaguchi
city: Gifu
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Symbicort Medical Science Director, MD
role: STUDY_DIRECTOR
References: