Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418AM4)(COMPLETED)

This study has been completed.

Study NCT00394355 Information provided by Schering-Plough

First Received on October 31, 2006. Last Updated on February 10, 2011 History of Changes

Results First Received: October 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: mometasone furoate dry powder inhaler Drug: fluticasone propionate hydrofluoroalkane (HFA) Drug: montelukast

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
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Reporting Groups

	Description
MF DPI 200 Mcg QD PM	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
MF DPI 400 Mcg QD PM	MF DPI 400 mcg QD PM for 1 year
FP MDI 250 Mcg BID	Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
ML 10 mg QD PM	Montelukast (ML) 10 mg QD PM for 1 year

Participant Flow: Overall Study

	MF DPI 200 Mcg QD PM	MF DPI 400 Mcg QD PM	FP MDI 250 Mcg BID	ML 10 mg QD PM
STARTED	140	137	147	142
COMPLETED	105	103	109	111
NOT COMPLETED	35	34	38	31
Adverse Event	10	6	7	8
Did not meet protocol eligibility	1	5	4	2
Subject withdrawal - unrelated to drug	12	14	10	6
Subject withdrawal - related to drug	1	0	0	0
Lost to Follow-up	7	5	4	3
Noncompliance with protocol	4	3	10	8
Administrative	0	1	1	1
Lack of Efficacy	0	0	2	3

Baseline Characteristics

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Reporting Groups

	Description
MF DPI 200 Mcg QD PM	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
MF DPI 400 Mcg QD PM	MF DPI 400 mcg QD PM for 1 year
FP MDI 250 Mcg BID	Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
ML 10 mg QD PM	Montelukast (ML) 10 mg QD PM for 1 year

Baseline Measures

	MF DPI 200 Mcg QD PM	MF DPI 400 Mcg QD PM	FP MDI 250 Mcg BID	ML 10 mg QD PM	Total
Number of Participants [units: participants]	140	137	147	142	566
Age [units: years] Mean ± Standard Deviation	29.7 ± 7.8	29.8 ± 8.1	28.2 ± 6.9	28.2 ± 7.1	29.0 ± 7.5
Gender [units: participants]
Female	91	90	90	88	359
Male	49	47	57	54	207

Outcome Measures

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1. Primary:

Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point [ Time Frame: Baseline and up to ~ one year of treatment ]

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2. Secondary:

Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point [ Time Frame: Baseline and up to ~ one year of treatment ]

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3. Secondary:

Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point [ Time Frame: Baseline and up to ~ one year of treatment ]

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4. Secondary:

Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second). [ Time Frame: Baseline and up to ~ one year of treatment ]

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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: Principal investigator (PI) agrees not to publish or publicly present any interim results of the study without prior written consent of the sponsor. The PI further agrees to provide to the sponsor, 30 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, PI agrees to meet with the sponsor, prior to submission for publication, to discuss and resolve any such issues or 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:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00394355 History of Changes
Other Study ID Numbers:	P03418, Doc ID: 3387777;, EUDRACT No: 2004-002930-21;
Study First Received:	October 31, 2006
Results First Received:	October 22, 2010
Last Updated:	February 10, 2011
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica