An Open, Phase III, Multicentre, 52-Week Study, Evaluating the Safety and Efficacy of Symbicort Turbuhaler (1, 2, and 4 x 160/4.5ug Twice Daily) in Japanese Patients With Asthma
- Conditions
- Asthma
- Registration Number
- JPRN-jRCT2080220267
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Ages Eligible for Study: 16 Years and above
Genders Eligible for Study: Both
Criteria
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 beta2-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
- 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method