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An Open-label Phase 3, Multi-centre 52-week, Parallel-group Study Evaluating the Safety and Efficacy of Symbicort Turbuhaler 320/9mcg Twice Daily Compared With Standard Treatment in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

An Open-label Phase 3, Multi-centre 52-week, Parallel-group Study Evaluating the Safety and Efficacy of Symbicort Turbuhaler 320/9mcg Twice Daily Compared With Standard Treatment in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221058
Enrollment
Unknown
Registered
2010-04-05
Start date
2010-04-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

investigational material(s) Generic name etc : Budesonide/formoterolTurbuhaler (ST) INN of investigational material : Budesonide/Formoterol Therapeutic category code : 229 Other agents affecting respi

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - A current clinical diagnosis of COPD according to the guidelines (GOLD, JPS) - Documented COPD symptoms for more than 2 years - Pre-bronchodilator FEV1 50% or less of predicted normal value, and post-bronchodilator FEV1/FVC less than 70%

Exclusion criteria

Exclusion criteria: - History and/or current clinical diagnosis of asthma and atopic diseases such as allergic rhinitis - Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator - COPD exacerbation during the run-in period or within 4 weeks prior to registration, requiring hospitalization and/or treatment with systemic steroids

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026