Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Formoterol (OT)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01047553

D5122C00002

Details and patient eligibility

About

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).

Enrollment

251 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Outpatients, men or women ≥ 40 years
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

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