Study identifier:D5122C00002
ClinicalTrials.gov identifier:NCT01047553
EudraCT identifier:N/A
CTIS identifier:N/A
An open phase III, multi-centre 52-week, parallel-group study evaluating the safety and efficacy of formoterol 18 μg daily dose compared with standard COPD treatment, in Japanese patients with chronic obstructive pulmonary disease (COPD)
Chronic Obstructive Pulmonary Disease
Phase 3
No
Formoterol (OT)
All
251
Interventional
40 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 May 2025 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be the group to refer to when safety results of formoterol arm will be evaluated. 240 patients with moderate-to-severe COPD will be randomised (120 patients in the formoterol-arm and 120 patients on standard COPD therapy).
Location
Location
AKITA-SHI, AKITA, Japan
Location
AKO, Hyogo, Japan
Location
BUNKYO, Tokyo, Japan
Location
CHITOSE, Hokkaido, Japan
Location
CHUO, Tokyo, Japan
Location
FUJISAWA, Kanagawa, Japan
Location
FUKUOKA, Fukuoka, Japan
Location
HITACHI, Ibaraki, Japan
Arms | Assigned Interventions |
---|---|
Experimental: 1 Formoterol 9 μg/dose | Drug: Formoterol (OT) 9 μg/dose, Inhaled, twice daily for 52 weeks Other Name: Oxis Turbuhaler® |
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