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

Phase 3

Completed

• Conditions: Asthma

• Registration Number: NCT00252785
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-11-11
• Study First Submitted QC: 2005-11-11
• Study First Posted: 2005-11-15
• Study Completion: 2006-11
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Morning peak expiratory flow (mPEF)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Toyama, Japan