MedDataX Logo

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

NCT ID: NCT00628862

Last Updated: 2012-10-25

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

613 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Chronic Obstructive Pulmonary Disease COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

F 4.5 bid

Formoterol 4.5 ug twice daily (bid)

Group Type EXPERIMENTAL

Formoterol Turbuhaler® 4.5mg

Intervention Type DRUG

4.5 mg inhaled twice daily

F 9.0 bid

Formoterol 9.0 ug bid

Group Type EXPERIMENTAL

Formoterol Turbuhaler® 9 mg

Intervention Type DRUG

9 mg inhaled twice daily

PBO

Placebo

Group Type PLACEBO_COMPARATOR

Turbuhaler® placebo

Intervention Type DRUG

placebo inhaled twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Formoterol Turbuhaler® 4.5mg

4.5 mg inhaled twice daily

Intervention Type DRUG

Formoterol Turbuhaler® 9 mg

9 mg inhaled twice daily

Intervention Type DRUG

Turbuhaler® placebo

placebo inhaled twice daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Oxis Oxis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lars-Goran Carlsson, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D Lund, Sweden

Miron A Bogdan, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Medic Or, Calea

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Gabrovo, , Bulgaria

Site Status

Research Site

Lovech, , Bulgaria

Site Status

Research Site

Pleven, , Bulgaria

Site Status

Research Site

Rousse, , Bulgaria

Site Status

Research Site

Sofia, , Bulgaria

Site Status

Research Site

Stara Zagora, , Bulgaria

Site Status

Research Site

Troyan Municipality, , Bulgaria

Site Status

Research Site

Varna, , Bulgaria

Site Status

Research Site

Nagoya, Aichi-ken, Japan

Site Status

Research Site

Seto, Aichi-ken, Japan

Site Status

Research Site

Noda, Chiba, Japan

Site Status

Research Site

Touon, Ehime, Japan

Site Status

Research Site

Yanagawa, Fukuoka, Japan

Site Status

Research Site

Ōta, Gunma, Japan

Site Status

Research Site

Ōwa, Gunma, Japan

Site Status

Research Site

Hiroshima, Hiroshima, Japan

Site Status

Research Site

Asahikawa, Hokkaido, 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

Tomakomai, Hokkaido, Japan

Site Status

Research Site

Yabu, Hyōgo, Japan

Site Status

Research Site

Naka-gun, Ibaraki, Japan

Site Status

Research Site

Morioka, Iwate, Japan

Site Status

Research Site

Kagoshima, Kagoshima-ken, Japan

Site Status

Research Site

Kawasaki, Kangawa, Japan

Site Status

Research Site

Kochi, Kochi, Japan

Site Status

Research Site

Kyoto, Kyoto, Japan

Site Status

Research Site

Sendai, Miyagi, Japan

Site Status

Research Site

Katano, Osaka, Japan

Site Status

Research Site

Kishiwada, Osaka, Japan

Site Status

Research Site

Osaka, Osaka, Japan

Site Status

Research Site

Takatsuiki, Osaka, Japan

Site Status

Research Site

Chiyoda City, Tokyo, Japan

Site Status

Research Site

Wakayama, Wakayama, Japan

Site Status

Research Site

Ube, Yamaguchi, Japan

Site Status

Research Site

Deva, Hunedoara County, Romania

Site Status

Research Site

Bucharest, , Romania

Site Status

Research Site

Constanța, , Romania

Site Status

Research Site

Iași, , Romania

Site Status

Research Site

Kazan', , Russia

Site Status

Research Site

Moscow, , Russia

Site Status

Research Site

Saint Petersburg, , Russia

Site Status

Research Site

Dnipropetrovsk, , Ukraine

Site Status

Research Site

Donetsk, , Ukraine

Site Status

Research Site

Kharkiv, , Ukraine

Site Status

Research Site

Kyiv, , Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bulgaria Japan Romania Russia Ukraine

References

Explore related publications, articles, or registry entries linked to this study.

Bogdan MA, Aizawa H, Fukuchi Y, Mishima M, Nishimura M, Ichinose M. Efficacy and safety of inhaled formoterol 4.5 and 9 mug twice daily in Japanese and European COPD patients: phase III study results. BMC Pulm Med. 2011 Nov 15;11:51. doi: 10.1186/1471-2466-11-51.

Reference Type DERIVED
PMID: 22085439 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT no 2007-003999-19

Identifier Type: -

Identifier Source: secondary_id

D5122C00001

Identifier Type: -

Identifier Source: org_study_id