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An Open Phase 3, Multi-centre 52-week, Parallel-group Study Evaluating the Safety and Efficacy of Formoterol 18mcg Daily Dose Compared With Standard COPD Treatment, in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

An Open Phase 3, Multi-centre 52-week, Parallel-group Study Evaluating the Safety and Efficacy of Formoterol 18mcg Daily Dose Compared With Standard COPD Treatment, in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221001
Enrollment
240
Registered
2010-02-10
Start date
2010-02-10
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

Interventions

investigational material(s) Generic name etc : Formoterol INN of investigational material : Formoterol Therapeutic category code : 225 Bronchodilators Dosage and Administration for Investigational mat

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - A clinical diagnosis of COPD according to guidelines, and current COPD symptoms. - Post-bronchodilator FEV1 <80% of predicted normal value and FEV1/FVC <70%, post-bronchodilator

Exclusion criteria

Exclusion criteria: - A history and/or current clinical diagnosis of asthma and atopic diseases such as Allergic rhinitis - Patients who have experienced COPD exacerbation requiring at least one of the following treatment, hospitalisation and/or a course of systemic steroid within 4 weeks prior to the study start. - Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator

Outcome results

None listed

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