A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD

This study has been completed.

Study NCT00419744 Information provided by AstraZeneca

First Received on January 5, 2007. Last Updated on August 18, 2010 History of Changes

Results First Received: August 18, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Chronic Obstructive Pulmonary Disease
Interventions:	Drug: Budesonide/formoterol (SYMBICORT) pMDI Drug: Formoterol Turbuhaler

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
First patient randomized on 02 January 2007. The last patient completed study on 27 August 2009. The study randomized patients in the United States and Mexico (93 investigational sites), South America (48 investigational sites), and South Africa (20 investigational sites).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of an initial screening visit (Visit 1) and 2-week run-in enrollment visits (Visits 2 and 3) prior to being randomized to 1 of 3 treatment groups

Reporting Groups

	Description
SYM 160/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
SYM 80/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
FOR 4.5 X 2 BID	Formoterol Turbuhaler 4.5 μg x 2 inhalations BID

Participant Flow: Overall Study

	SYM 160/4.5 X 2 BID	SYM 80/4.5 X 2 BID	FOR 4.5 X 2 BID
STARTED	407	408	404
COMPLETED	290	290	271
NOT COMPLETED	117	118	133
Adverse Event	39	40	50
Withdrawal by Subject	45	49	52
Lost to Follow-up	8	10	6
Protocol Violation	4	7	8
Randomized in error	9	6	7
Moving out of state	2	0	1
Physician Decision	10	5	6
Spirometry mouthpiece issues	0	1	2
Incorrect medication kit dispensed	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
SYM 160/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
SYM 80/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
FOR 4.5 X 2 BID	Formoterol Turbuhaler 4.5 μg x 2 inhalations BID

Baseline Measures

	SYM 160/4.5 X 2 BID	SYM 80/4.5 X 2 BID	FOR 4.5 X 2 BID	Total
Number of Participants [units: participants]	407	408	403	1218
Age [units: Years] Mean ± Standard Deviation	63.8 ± 9.4	62.8 ± 9.22	62.5 ± 9.36	63.0 ± 9.34
Gender [units: Participants]
Female	145	144	174	463
Male	262	264	229	755

Outcome Measures

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1. Primary:

Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year [ Time Frame: 12 months ]

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2. Primary:

Rate of Exacerbations Per Subject-year [ Time Frame: 12 months ]

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3. Secondary:

Pre-dose Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 months ]

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4. Secondary:

Morning Peak Expiratory Flow (PEF) [ Time Frame: 12 months ]

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5. Secondary:

Evening PEF [ Time Frame: 12 months ]

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6. Secondary:

Dyspnea Symptom Scores [ Time Frame: 12 months ]

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7. Secondary:

Use of Rescue Medication [ Time Frame: 12 months ]

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8. Secondary:

St. George's Respiratory Questionnaire (SGRQ) Score [ Time Frame: 12 months ]

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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. Restriction Description: The PI may use the Multi-Center Study Results and the Site Data for the limited purpose of his or her own research and academic analysis until the earlier of the publication of the first Multi-center Publication and the second anniversary of the completion of the Multi-center Study at all participating sites.

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
N/A

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:

Sharafkhaneh A, Southard JG, Goldman M, Uryniak T, Martin UJ. Effect of budesonide/formoterol pMDI on COPD exacerbations: a double-blind, randomized study. Respir Med. 2012 Feb;106(2):257-68. Epub 2011 Oct 26.

ClinicalTrials.gov Identifier:	NCT00419744 History of Changes
Other Study ID Numbers:	D589CC00003
Study First Received:	January 5, 2007
Results First Received:	August 18, 2010
Last Updated:	August 18, 2010
Health Authority:	United States: Food and Drug Administration