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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

NCT ID: NCT01047553

Last Updated: 2013-01-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-07-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Formoterol 9 μg/dose

Group Type EXPERIMENTAL

Formoterol (OT)

Intervention Type DRUG

9 μg/dose, Inhaled, twice daily for 52 weeks

Interventions

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Formoterol (OT)

9 μg/dose, Inhaled, twice daily for 52 weeks

Intervention Type DRUG

Other Intervention Names

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Oxis Turbuhaler®

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Nagoya, Aichi-ken, Japan

Site Status

Research Site

Akita, Akita, Japan

Site Status

Research Site

Fukuoka, Fukuoka, Japan

Site Status

Research Site

Chitose, Hokkaido, Japan

Site Status

Research Site

Obihiro, Hokkaido, Japan

Site Status

Research Site

Sapporo, Hokkaido, Japan

Site Status

Research Site

Ako, Hyōgo, Japan

Site Status

Research Site

Kobe, Hyōgo, Japan

Site Status

Research Site

Hitachi, Ibaraki, Japan

Site Status

Research Site

Tsukuba, Ibaraki, Japan

Site Status

Research Site

Kanazawa, Ishikawa-ken, Japan

Site Status

Research Site

Sakaidechō, Kagawa-ken, Japan

Site Status

Research Site

Fujisawa, Kanagawa, Japan

Site Status

Research Site

Kawasaki-shi, Kanagawa, Japan

Site Status

Research Site

Yokohama, Kanagawa, Japan

Site Status

Research Site

Kōshi, Kumamoto, Japan

Site Status

Research Site

Kyoto, Kyoto, Japan

Site Status

Research Site

Nagaoka, Niigata, Japan

Site Status

Research Site

Saiki-shi, Oita Prefecture, Japan

Site Status

Research Site

Moriguchi, Osaka, Japan

Site Status

Research Site

Matsue, Shimane, Japan

Site Status

Research Site

Bunkyo, Tokyo, Japan

Site Status

Research Site

Chūō, Tokyo, Japan

Site Status

Research Site

Katsushika-ku, Tokyo, Japan

Site Status

Research Site

Kodaira, Tokyo, Japan

Site Status

Research Site

Setagaya City, Tokyo, Japan

Site Status

Research Site

Tosima-ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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D5122C00002

Identifier Type: -

Identifier Source: org_study_id

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