Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU (OCEAN)
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ClinicalTrials.gov Identifier: NCT00628862 |
Recruitment Status
:
Completed
First Posted
: March 5, 2008
Results First Posted
: October 25, 2012
Last Update Posted
: October 25, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease | Drug: Formoterol Turbuhaler® 4.5mg Drug: Formoterol Turbuhaler® 9 mg Drug: Turbuhaler® placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 613 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | April 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: F 4.5 bid
Formoterol 4.5 ug twice daily (bid)
|
Drug: Formoterol Turbuhaler® 4.5mg
4.5 mg inhaled twice daily
Other Name: Oxis
|
Experimental: F 9.0 bid
Formoterol 9.0 ug bid
|
Drug: Formoterol Turbuhaler® 9 mg
9 mg inhaled twice daily
Other Name: Oxis
|
Placebo Comparator: PBO
Placebo
|
Drug: Turbuhaler® placebo
placebo inhaled twice daily
|
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.

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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628862

Study Director: | Lars-Goran Carlsson, MD | AstraZeneca R&D Lund, Sweden | |
Principal Investigator: | Miron A Bogdan, MD | Clinica Medic Or, Calea |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00628862 History of Changes |
Other Study ID Numbers: |
D5122C00001 EudraCT no 2007-003999-19 |
First Posted: | March 5, 2008 Key Record Dates |
Results First Posted: | October 25, 2012 |
Last Update Posted: | October 25, 2012 |
Last Verified: | September 2012 |
Keywords provided by AstraZeneca:
Chronic Obstructive Pulmonary Disease COPD |
Additional relevant MeSH terms:
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Formoterol Fumarate Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Asthmatic Agents Respiratory System Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |