- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00628862
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
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Gabrovo, Bulgaria
- Research Site
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Lovech, Bulgaria
- Research Site
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Pleven, Bulgaria
- Research Site
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Russe, Bulgaria
- Research Site
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Sofia, Bulgaria
- Research Site
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Stara Zagora, Bulgaria
- Research Site
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Troyan, Bulgaria
- Research Site
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Varna, Bulgaria
- Research Site
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Hiroshima, Japan
- Research Site
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Kagoshima, Japan
- Research Site
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Kochi, Japan
- Research Site
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Kyoto, Japan
- Research Site
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Osaka, Japan
- Research Site
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Wakayama, Japan
- Research Site
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Aichi
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Nagoya, Aichi, Japan
- Research Site
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Seto, Aichi, Japan
- Research Site
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Chiba
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Noda, Chiba, Japan
- Research Site
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Ehime
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Touon, Ehime, Japan
- Research Site
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Fukuoka
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Yanagawa, Fukuoka, Japan
- Research Site
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Gunma
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ORA, Gunma, Japan
- Research Site
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OTA, Gunma, Japan
- Research Site
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Hokkaido
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Asahikawa, Hokkaido, Japan
- Research Site
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Chitose, Hokkaido, Japan
- Research Site
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Obihiro, Hokkaido, Japan
- Research Site
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Sapporo, Hokkaido, Japan
- Research Site
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Tomakomai, Hokkaido, Japan
- Research Site
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Hyogo
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Yabu, Hyogo, Japan
- Research Site
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Ibaraki
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Naka-gun, Ibaraki, Japan
- Research Site
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Iwate
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Morioka, Iwate, Japan
- Research Site
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Kangawa
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Kawasaki, Kangawa, Japan
- Research Site
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Miyagi
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Sendai, Miyagi, Japan
- Research Site
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Osaka
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Katano, Osaka, Japan
- Research Site
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Kishiwada, Osaka, Japan
- Research Site
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Takatsuiki, Osaka, Japan
- Research Site
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Tokyo
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Chiyoda, Tokyo, Japan
- Research Site
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Yamaguchi
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UBE, Yamaguchi, Japan
- Research Site
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Bucharest, Romania
- Research Site
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Bucuresti, Romania
- Research Site
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Constanta, Romania
- Research Site
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Iasi, Romania
- Research Site
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Hunedoara
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Deva, Hunedoara, Romania
- Research Site
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Kazan, Russian Federation
- Research Site
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Moscow, Russian Federation
- Research Site
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St. Petersburg, Russian Federation
- Research Site
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Dnipropetrovsk, Ukraine
- Research Site
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Donetsk, Ukraine
- Research Site
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Kharkiv, Ukraine
- Research Site
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Kyiv, Ukraine
- Research Site
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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 |
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Placebo Comparator: PBO
Placebo
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placebo inhaled twice daily
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Experimental: F 4.5 bid
Formoterol 4.5 ug twice daily (bid)
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4.5 mg inhaled twice daily
Other Names:
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Experimental: F 9.0 bid
Formoterol 9.0 ug bid
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9 mg inhaled twice daily
Other Names:
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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
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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.
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from baseline up to 12 weeks
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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
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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
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from baseline up to 12 weeks
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FEV1 Pre-dose
Time Frame: baseline at week 0 and pre-dose at weeks 4, 8 and 12
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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
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baseline at week 0 and pre-dose at weeks 4, 8 and 12
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FVC Pre-dose
Time Frame: baseline at week 0 and pre-dose at weeks 4, 8 and 12
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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
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baseline at week 0 and pre-dose at weeks 4, 8 and 12
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FEV1 5 Minutes Post-dose
Time Frame: baseline and 5 minutes anter first dose
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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
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baseline and 5 minutes anter first dose
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FVC 5 Minutes Post-dose
Time Frame: baseline and 5 minutes anter first dose
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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
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baseline and 5 minutes anter first dose
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Change in Peak Expiratory Flow (PEF), Morning
Time Frame: run-in period and 12 week
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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
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run-in period and 12 week
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Change in Peak Expiratory Flow (PEF), Evening
Time Frame: run-in period and 12 week
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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
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run-in period and 12 week
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Change in Night-time Awakenings Due to Symptoms
Time Frame: run-in period up to 12 weeks
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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
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run-in period up to 12 weeks
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Breathlessness
Time Frame: run-in period up to 12 weeks
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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
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run-in period up to 12 weeks
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Cough
Time Frame: run-in period up to 12 weeks
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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
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run-in period up to 12 weeks
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Use of Reliever Medication
Time Frame: 12 weeks (end of run-in to last visit)
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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
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12 weeks (end of run-in to last visit)
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St George's Respiratory Questionnaire (SGRQ)
Time Frame: 12 weeks (end of run-in to last visit)
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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.
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12 weeks (end of run-in to last visit)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Formoterol Fumarate
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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