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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
Results First Received: March 19, 2010  
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
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Formoterol Turbuhaler® 4.5mg
Drug: Formoterol Turbuhaler® 9 mg
Drug: Turbuhaler® placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Outpatients, male or female aged ≥ 40 years with moderate to severe chronic obstructive pulmonary disease (COPD). 766 subjects enrolled; 153 excluded: 96 for incorrect enrollment, 17 for adverse events, 32 for voluntary discontinuation, 1 for non-compliance with protocol, 7 for other reasons. 613 were randomised.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Formoterol 4.5 Bid Formoterol 4.5 ug bid
Formoterol 9.0 Bid Formoterol 9.0 ug bid
Placebo Placebo

Participant Flow:   Overall Study
    Formoterol 4.5 Bid   Formoterol 9.0 Bid   Placebo
STARTED   206 [1]   199 [1]   208 [1] 
COMPLETED   195 [1]   182 [1]   186 [1] 
NOT COMPLETED   11   17   22 
Adverse Event                6                8                10 
Withdrawal by Subject                4                6                11 
Lost to Follow-up                0                2                1 
Protocol Violation                1                0                0 
COPD Exacerbation                0                1                0 
[1] randomised patients



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Formoterol 4.5 Bid Formoterol 4.5 ug bid
Formoterol 9.0 Bid Formoterol 9.0 ug bid
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
   Formoterol 4.5 Bid   Formoterol 9.0 Bid   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 206   199   208   613 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.7  (9.4)   67.2  (9.2)   66.3  (9.7)   66.75  (9.4) 
Gender 
[Units: Participants]
       
Female   23   29   22   74 
Male   183   170   186   539 


  Outcome Measures
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1.  Primary:   Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose   [ Time Frame: from baseline up to 12 weeks ]

2.  Secondary:   Forced Vital Capacity (FVC) 60 Minutes Post-dose   [ Time Frame: from baseline up to 12 weeks ]

3.  Secondary:   FEV1 Pre-dose   [ Time Frame: baseline at week 0 and pre-dose at weeks 4, 8 and 12 ]

4.  Secondary:   FVC Pre-dose   [ Time Frame: baseline at week 0 and pre-dose at weeks 4, 8 and 12 ]

5.  Secondary:   FEV1 5 Minutes Post-dose   [ Time Frame: baseline and 5 minutes anter first dose ]

6.  Secondary:   FVC 5 Minutes Post-dose   [ Time Frame: baseline and 5 minutes anter first dose ]

7.  Secondary:   Change in Peak Expiratory Flow (PEF), Morning   [ Time Frame: run-in period and 12 week ]

8.  Secondary:   Change in Peak Expiratory Flow (PEF), Evening   [ Time Frame: run-in period and 12 week ]

9.  Secondary:   Change in Night-time Awakenings Due to Symptoms   [ Time Frame: run-in period up to 12 weeks ]

10.  Secondary:   Breathlessness   [ Time Frame: run-in period up to 12 weeks ]

11.  Secondary:   Cough   [ Time Frame: run-in period up to 12 weeks ]

12.  Secondary:   Use of Reliever Medication   [ Time Frame: 12 weeks (end of run-in to last visit) ]

13.  Secondary:   St George’s Respiratory Questionnaire (SGRQ)   [ Time Frame: 12 weeks (end of run-in to last visit) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


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