Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (Study P04139AM1)(COMPLETED)

This study has been completed.

Study NCT00379288 Information provided by Schering-Plough

First Received on September 19, 2006. Last Updated on October 26, 2010 History of Changes

Results First Received: July 15, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: mometasone furoate combination MDI 200/10 mcg BID Drug: mometasone furoate combination MDI 400/10 mcg BID Drug: Fluticasone/Salmeterol 250/50 mcg BID Drug: Fluticasone/Salmeterol 500/50 mcg BID

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects starting study are those subjects who completed screening procedures and randomized.

Reporting Groups

	Description
MF/F 200/10 Mcg BID	mometasone furoate/formoterol (MF/F) 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
MF/F 400/10 Mcg BID	MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
F/SC 250/50 Mcg BID	fluticasone/salmeterol combination (F/SC) 250/50 twice daily for 1 year
F/SC 500/50 Mcg BID	F/SC 500/50 twice daily for 1 year

Participant Flow: Overall Study

	MF/F 200/10 Mcg BID	MF/F 400/10 Mcg BID	F/SC 250/50 Mcg BID	F/SC 500/50 Mcg BID
STARTED	141	130	68	65
COMPLETED	122	108	58	57
NOT COMPLETED	19	22	10	8
Adverse Event	5	6	2	0
Treatment Failure	0	1	0	1
Lost to Follow-up	3	3	2	0
Subject withdrew-unrelated to study drug	0	3	4	2
Subject withdrew-related to study drug	1	0	0	1
Noncompliance with protocol	8	6	2	1
Did not meet protocol eligibility	0	1	0	2
Administrative	2	2	0	1

Baseline Characteristics

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Reporting Groups

	Description
MF/F 200/10 Mcg BID	MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
MF/F 400/10 Mcg BID	MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
F/SC 250/50 Mcg BID	F/SC 250/50 twice daily for 1 year
F/SC 500/50 Mcg BID	F/SC 500/50 twice daily for 1 year

Baseline Measures

	MF/F 200/10 Mcg BID	MF/F 400/10 Mcg BID	F/SC 250/50 Mcg BID	F/SC 500/50 Mcg BID	Total
Number of Participants [units: participants]	141	130	68	65	404
Age [units: years] Mean ± Standard Deviation	32.7 ± 15.2	39.3 ± 14.5	32.4 ± 14.9	37.1 ± 15.0	35.5 ± 15.2
Gender [units: participants]
Female	92	86	38	40	256
Male	49	44	30	25	148

Outcome Measures

1. Primary:

The Number of All Randomized Subjects Reporting Adverse Events (AEs). [ Time Frame: 1 year ]

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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 investigator agrees not to publish/present any interim results without prior sponsor written consent. The investigator agrees to provide to the sponsor, 45 days prior to submission, review copies for publication that report any study results. The sponsor has the right to review and comment. If the parties disagree, investigator agrees to meet with the sponsor, prior to submission for publication, to discuss and resolve any such issues/disagreement.

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: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Schering-Plough (Head, Clinical Trials Registry & Results Disclosure Group)
ClinicalTrials.gov Identifier:	NCT00379288 History of Changes
Other Study ID Numbers:	P04139
Study First Received:	September 19, 2006
Results First Received:	July 15, 2010
Last Updated:	October 26, 2010
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Peru: National Institute of Health; Mexico: Ministry of Health; Chile: Instituto de Salud Publica de Chile; Ecuador: Public Health Ministry; Guatemala:Ministry of Public Health and Social Welfare