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

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
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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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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
Number of Participants [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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

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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Results Point of Contact:

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

No publications provided by AstraZeneca

Publications automatically indexed to this study:

Bogdan MA, Aizawa H, Fukuchi Y, Mishima M, Nishimura M, Ichinose M. Efficacy and safety of inhaled formoterol 4.5 and 9 ?g twice daily in Japanese and European COPD patients: phase III study results. BMC Pulm Med. 2011 Nov 15;11:51.

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

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