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

January 24, 2008
September 25, 2012
December 2007
April 2009   (final data collection date for primary outcome measure)
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.
To show that formoterol 4.5 μg and 9 μg twice daily are superior to placebo in Japanese and European COPD patients treated for 12 weeks by evaluation of FEV1 60 minutes post-dose as the primary outcome variable. [ Time Frame: evaluated 60 minutes post-dose for 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00628862 on ClinicalTrials.gov Archive Site
  • 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.
  • Evaluate the onset of action of formoterol 4.5 μg and 9 μg using placebo as a control, by evaluation of FEV1 as the primary objective [ Time Frame: Evaluated 5 minutes post-dose at Visit 3 ] [ Designated as safety issue: No ]
  • Compare the effect of formoterol 4.5 μg twice daily to that of formoterol 9 μg twice daily by evaluation of the same primary and secondary variables as for the primary objective [ Time Frame: evaluated at each visit for 12 weeks ] [ Designated as safety issue: No ]
  • Evaluate the safety of formoterol 4.5 μg and 9 μg twice daily for 12 weeks in terms of: - Adverse events, laboratory variables, 12-lead ECG, blood pressure and pulse rate [ Time Frame: evaluated at each visit for 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Formoterol Turbuhaler® 4.5mg
    4.5 mg inhaled twice daily
    Other Name: Oxis
  • Drug: Formoterol Turbuhaler® 9 mg
    9 mg inhaled twice daily
    Other Name: Oxis
  • Drug: Turbuhaler® placebo
    placebo inhaled twice daily
  • Experimental: F 4.5 bid
    Formoterol 4.5 ug twice daily (bid)
    Intervention: Drug: Formoterol Turbuhaler® 4.5mg
  • Experimental: F 9.0 bid
    Formoterol 9.0 ug bid
    Intervention: Drug: Formoterol Turbuhaler® 9 mg
  • Placebo Comparator: PBO
    Placebo
    Intervention: Drug: Turbuhaler® placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
613
April 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Bulgaria,   Ukraine,   Romania,   Russian Federation
 
NCT00628862
D5122C00001, EudraCT no 2007-003999-19
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Lars-Goran Carlsson, MD AstraZeneca R&D Lund, Sweden
Principal Investigator: Miron A Bogdan, MD Clinica Medic Or, Calea
AstraZeneca
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP