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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00628862
First received: January 24, 2008
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: Formoterol Turbuhaler® 4.5mg
Drug: Formoterol Turbuhaler® 9 mg
Drug: Turbuhaler® placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose [ Time Frame: from baseline up to 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 613
Study Start Date: December 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by AstraZeneca

Additional 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
Study First Received: January 24, 2008
Results First Received: March 19, 2010
Last Updated: September 25, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Bulgaria: Bulgarian Drug Agency
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health

Keywords provided by AstraZeneca:
Chronic Obstructive Pulmonary Disease
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013