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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Formoterol Turbuhaler® 4.5mg
Formoterol Turbuhaler® 9 mg
Turbuhaler® placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

F 4.5 bid

F 9.0 bid

PBO

Arm Description

Formoterol 4.5 ug twice daily (bid)

Formoterol 9.0 ug bid

Placebo

Outcomes

Primary Outcome Measures

Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose
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
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
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
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
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
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
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
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
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
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
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
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)
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.

Full Information

First Posted
January 24, 2008
Last Updated
September 25, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00628862
Brief Title
Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU
Acronym
OCEAN
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
613 (Actual)

8. Arms, Groups, and Interventions

Arm Title
F 4.5 bid
Arm Type
Experimental
Arm Description
Formoterol 4.5 ug twice daily (bid)
Arm Title
F 9.0 bid
Arm Type
Experimental
Arm Description
Formoterol 9.0 ug bid
Arm Title
PBO
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Formoterol Turbuhaler® 4.5mg
Other Intervention Name(s)
Oxis
Intervention Description
4.5 mg inhaled twice daily
Intervention Type
Drug
Intervention Name(s)
Formoterol Turbuhaler® 9 mg
Other Intervention Name(s)
Oxis
Intervention Description
9 mg inhaled twice daily
Intervention Type
Drug
Intervention Name(s)
Turbuhaler® placebo
Intervention Description
placebo inhaled twice daily
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose
Description
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.
Time Frame
from baseline up to 12 weeks
Secondary Outcome Measure Information:
Title
Forced Vital Capacity (FVC) 60 Minutes Post-dose
Description
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
Time Frame
from baseline up to 12 weeks
Title
FEV1 Pre-dose
Description
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
Time Frame
baseline at week 0 and pre-dose at weeks 4, 8 and 12
Title
FVC Pre-dose
Description
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
Time Frame
baseline at week 0 and pre-dose at weeks 4, 8 and 12
Title
FEV1 5 Minutes Post-dose
Description
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
Time Frame
baseline and 5 minutes anter first dose
Title
FVC 5 Minutes Post-dose
Description
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
Time Frame
baseline and 5 minutes anter first dose
Title
Change in Peak Expiratory Flow (PEF), Morning
Description
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
Time Frame
run-in period and 12 week
Title
Change in Peak Expiratory Flow (PEF), Evening
Description
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
Time Frame
run-in period and 12 week
Title
Change in Night-time Awakenings Due to Symptoms
Description
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
Time Frame
run-in period up to 12 weeks
Title
Breathlessness
Description
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
Time Frame
run-in period up to 12 weeks
Title
Cough
Description
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
Time Frame
run-in period up to 12 weeks
Title
Use of Reliever Medication
Description
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
Time Frame
12 weeks (end of run-in to last visit)
Title
St George's Respiratory Questionnaire (SGRQ)
Description
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.
Time Frame
12 weeks (end of run-in to last visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars-Goran Carlsson, MD
Organizational Affiliation
AstraZeneca R&D Lund, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Miron A Bogdan, MD
Organizational Affiliation
Clinica Medic Or, Calea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Gabrovo
Country
Bulgaria
Facility Name
Research Site
City
Lovech
Country
Bulgaria
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Russe
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Stara Zagora
Country
Bulgaria
Facility Name
Research Site
City
Troyan
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Seto
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Noda
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Touon
State/Province
Ehime
Country
Japan
Facility Name
Research Site
City
Yanagawa
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
ORA
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
OTA
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Chitose
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Obihiro
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Tomakomai
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Yabu
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Naka-gun
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Morioka
State/Province
Iwate
Country
Japan
Facility Name
Research Site
City
Kawasaki
State/Province
Kangawa
Country
Japan
Facility Name
Research Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Katano
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Kishiwada
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Takatsuiki
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Chiyoda
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
UBE
State/Province
Yamaguchi
Country
Japan
Facility Name
Research Site
City
Hiroshima
Country
Japan
Facility Name
Research Site
City
Kagoshima
Country
Japan
Facility Name
Research Site
City
Kochi
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan
Facility Name
Research Site
City
Osaka
Country
Japan
Facility Name
Research Site
City
Wakayama
Country
Japan
Facility Name
Research Site
City
Deva
State/Province
Hunedoara
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Constanta
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Kazan
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
22085439
Citation
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.
Results Reference
derived

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

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