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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255255
• Other study ID #: D5890C00009
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2005
• Last updated: January 21, 2011
• Start date: November 2005
• Est. completion date: June 2007

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 ß2-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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide/Formoterol

Locations

Country	Name	City	State
Japan	Research Site	Beppu	Ohita
Japan	Research Site	Gifu
Japan	Research Site	Hiroshima
Japan	Research Site	Kagoshima
Japan	Research Site	Kishiwada	Osaka
Japan	Research Site	Kochi
Japan	Research Site	Komaki	Aichi
Japan	Research Site	Morioka	Iwate
Japan	Research Site	Ora	Gunma
Japan	Research Site	Ota-ku	Tokyo
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Seto	Aichi
Japan	Research Site	Shinjuku-ku	Tokyo
Japan	Research Site	Takamatsu	Kagawa
Japan	Research Site	Takatsuki	Osaka
Japan	Research Site	Tomakomai	Hokkaido
Japan	Research Site	Tsukubo-gun	Okayama
Japan	Research Site	Ube	Yamaguchi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient reported outcomes regarding disease status (incl. PEF), collected via diaries
Secondary	Forced expiratory volume in one second (FEV1)
Secondary	- all variables assessed over the 52 week treatment period