Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU (OCEAN)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Formoterol Turbuhaler® 4.5mg; Drug: Formoterol Turbuhaler® 9 mg; Drug: Turbuhaler® placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00628862

D5122C00001

EudraCT no 2007-003999-19

Details and patient eligibility

About

The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.

Enrollment: 613 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms
• Current or previous smoker with a smoking history of 10 or more pack years
• Lung function parameters: FEV1/FVC < 70%, post-bronchodilator and post-bronchodilator FEV1 < 80% of predicted normal value

Exclusion criteria

• History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis
• Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2
• Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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613 participants in 3 patient groups, including a placebo group

F 4.5 bid

Experimental group

Description:

Formoterol 4.5 ug twice daily (bid)

Treatment:

Drug: Formoterol Turbuhaler® 4.5mg

F 9.0 bid

Experimental group

Description:

Formoterol 9.0 ug bid

Treatment:

Drug: Formoterol Turbuhaler® 9 mg

PBO

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Turbuhaler® placebo