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”

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.

Study Type: Interventional

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

Study Primary Completion Date: November 2006

Intervention(s) in this Clinical Trial

• Drug: Budesonide/Formoterol
• Drug: Budesonide
• Drug: Theophylline

Primary Measures

• Morning peak expiratory flow (mPEF)

Secondary Measures

• 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

AstraZeneca Symbicort Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00252785

Study ID Number: D5890C00010

ClinicalTrials.gov Identifier: NCT00252785

Health Authority: Japan: Ministry of Health, Labor and Welfare