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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide/Formoterol
* Drug: Budesonide
* Drug: Theophylline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Budesonide/Formoterol|nan|
|Drug: Budesonide|nan|
|Drug: Theophylline|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morning peak expiratory flow (mPEF) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma