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

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Description

Brief Summary:

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.

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 Design


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Drug Information available for: Formoterol fumarate Formoterol Arformoterol Tartrate

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

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

Show 48 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bogdan MA, Aizawa H, Fukuchi Y, Mishima M, Nishimura M, Ichinose M. Efficacy and safety of inhaled formoterol 4.5 and 9 μg 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.


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

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