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

September 25, 2012 updated by: AstraZeneca

A 12-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-national, Phase III, Efficacy and Safety Study of Inhaled Formoterol 4.5 μg and 9 μg Twice Daily in Japanese and European Patients With Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

613

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Gabrovo, Bulgaria
        • Research Site
      • Lovech, Bulgaria
        • Research Site
      • Pleven, Bulgaria
        • Research Site
      • Russe, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Stara Zagora, Bulgaria
        • Research Site
      • Troyan, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
  • Japan
      • Hiroshima, Japan
        • Research Site
      • Kagoshima, Japan
        • Research Site
      • Kochi, Japan
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Wakayama, Japan
        • Research Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Research Site
      • Seto, Aichi, Japan
        • Research Site
    • Chiba
      • Noda, Chiba, Japan
        • Research Site
    • Ehime
      • Touon, Ehime, Japan
        • Research Site
    • Fukuoka
      • Yanagawa, Fukuoka, Japan
        • Research Site
    • Gunma
      • ORA, Gunma, Japan
        • Research Site
      • OTA, Gunma, Japan
        • Research Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
        • Research Site
      • Chitose, Hokkaido, Japan
        • Research Site
      • Obihiro, Hokkaido, Japan
        • Research Site
      • Sapporo, Hokkaido, Japan
        • Research Site
      • Tomakomai, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Yabu, Hyogo, Japan
        • Research Site
    • Ibaraki
      • Naka-gun, Ibaraki, Japan
        • Research Site
    • Iwate
      • Morioka, Iwate, Japan
        • Research Site
    • Kangawa
      • Kawasaki, Kangawa, Japan
        • Research Site
    • Miyagi
      • Sendai, Miyagi, Japan
        • Research Site
    • Osaka
      • Katano, Osaka, Japan
        • Research Site
      • Kishiwada, Osaka, Japan
        • Research Site
      • Takatsuiki, Osaka, Japan
        • Research Site
    • Tokyo
      • Chiyoda, Tokyo, Japan
        • Research Site
    • Yamaguchi
      • UBE, Yamaguchi, Japan
        • Research Site
  • Romania
      • Bucharest, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Constanta, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
    • Hunedoara
      • Deva, Hunedoara, Romania
        • Research Site
  • Russian Federation
      • Kazan, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Donetsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PBO
Placebo
Drug: Turbuhaler® placebo
placebo inhaled twice daily
Experimental: F 4.5 bid
Formoterol 4.5 ug twice daily (bid)
Drug: Formoterol Turbuhaler® 4.5mg
4.5 mg inhaled twice daily
Other Names:
  • Oxis
Experimental: F 9.0 bid
Formoterol 9.0 ug bid
Drug: Formoterol Turbuhaler® 9 mg
9 mg inhaled twice daily
Other Names:
  • Oxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose
Time Frame: from baseline up to 12 weeks
FEV1 (expressed as litres [L]) is a spirometric measure of lung function. FEV1 was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value.
from baseline up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity (FVC) 60 Minutes Post-dose
Time Frame: from baseline up to 12 weeks
Forced Vital Capacity (FVC) is a spirometric measure of lung function. FVC was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value
from baseline up to 12 weeks
FEV1 Pre-dose
Time Frame: baseline at week 0 and pre-dose at weeks 4, 8 and 12
Lung function (FEV1) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value
baseline at week 0 and pre-dose at weeks 4, 8 and 12
FVC Pre-dose
Time Frame: baseline at week 0 and pre-dose at weeks 4, 8 and 12
Lung function (FVC) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value
baseline at week 0 and pre-dose at weeks 4, 8 and 12
FEV1 5 Minutes Post-dose
Time Frame: baseline and 5 minutes anter first dose
Lung function (FEV1) was measured 5 minutes after the first dose of study drug. The results are expressed as a percentage in relation to the baseline value
baseline and 5 minutes anter first dose
FVC 5 Minutes Post-dose
Time Frame: baseline and 5 minutes anter first dose
Lung function (FVC) was measured 5 minutes after the first dose of study drug, The results are expressed as a percentage in relation to the baseline value
baseline and 5 minutes anter first dose
Change in Peak Expiratory Flow (PEF), Morning
Time Frame: run-in period and 12 week
Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the morning). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
run-in period and 12 week
Change in Peak Expiratory Flow (PEF), Evening
Time Frame: run-in period and 12 week
Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the evening). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
run-in period and 12 week
Change in Night-time Awakenings Due to Symptoms
Time Frame: run-in period up to 12 weeks
Patients were asked to record the night-time awakenings due to symptoms (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
run-in period up to 12 weeks
Breathlessness
Time Frame: run-in period up to 12 weeks
Patients were asked to record breathlessness (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
run-in period up to 12 weeks
Cough
Time Frame: run-in period up to 12 weeks
Patients were asked to record cough (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
run-in period up to 12 weeks
Use of Reliever Medication
Time Frame: 12 weeks (end of run-in to last visit)
Patients were asked to record reliever medication use. Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
12 weeks (end of run-in to last visit)
St George's Respiratory Questionnaire (SGRQ)
Time Frame: 12 weeks (end of run-in to last visit)
Patients were asked to complete the St George's Respiratory Questionnaire (SGRQ). Subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life. A score of 0 indicates the best possible status. Results are expressed as the change from baseline score with a decrease in score indicating improvement.
12 weeks (end of run-in to last visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Lars-Goran Carlsson, MD, AstraZeneca R&D Lund, Sweden
  • Principal Investigator: Miron A Bogdan, MD, Clinica Medic Or, Calea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Estimate)

October 25, 2012

Last Update Submitted That Met QC Criteria

September 25, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5122C00001
  • EudraCT no 2007-003999-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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