Clinical trial NCT00255255: Safety & Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-18
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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:
measure: Patient reported outcomes regarding disease status (incl. PEF), collected via diaries
measure: Forced expiratory volume in one second (FEV1)
measure: - all variables assessed over the 52 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: Ora
country: Japan
facility: Research Site
state: Gunma
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: Beppu
country: Japan
facility: Research Site
state: Ohita
city: Tsukubo-gun
country: Japan
facility: Research Site
state: Okayama
city: Kishiwada
country: Japan
facility: Research Site
state: Osaka
city: Takatsuki
country: Japan
facility: Research Site
state: Osaka
city: Ota-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku-ku
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: Kochi
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Symbicort Medical Science Director, MD
role: STUDY_DIRECTOR
References: