Asthma
Conditions
Keywords
Asthma
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.
Interventions
DRUGBudesonide/Formoterol
DRUGBudesonide
DRUGTheophylline
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morning peak expiratory flow (mPEF) | — |
Secondary
| Measure | Time frame |
|---|---|
| Forced expiratory volume in one second (FEV1) | — |
| Safety: | — |
| Adverse events (nature, incidence and severity) | — |
| Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries | — |
| 12-lead ECGs, blood pressure, pulse rate | — |
| - all variables assessed over the 8 week treatment period | — |
| Haematology, clinical chemistry and urinalysis | — |
Countries
Japan
Outcome results
None listed