Asthma Study Comparing Anti-Inflammatory Effects of 3 Doses of Mometasone Furoate/Formoterol Fumarate and Medium Dose Mometasone Furoate (Study P05122 AM1)(COMPLETED)

This study has been completed.

Study NCT00635882 Information provided by Schering-Plough

First Received on January 21, 2008. Last Updated on February 10, 2011 History of Changes

Results First Received: October 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Conditions:	Asthma Airway Inflammation
Interventions:	Drug: mometasone furoate/formoterol 100/10 mcg Drug: mometasone furoate/formoterol 200/10 mcg Drug: mometasone furoate/formoterol 400/10 mcg Drug: MF DPI 200 mcg Drug: MF MDI 200 mcg Drug: 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
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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/F MDI 100/10 Mcg	Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
MF/F MDI 200/10 Mcg	MF/F MDI 200/10 mcg BID for 14 days
MF/F MDI 400/10 Mcg	MF/F MDI 400/10 mcg BID for 14 days
MF DPI 200 Mcg	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
MF MDI 200 Mcg	MF MDI 200 mcg BID for 14 days
Placebo	Placebo MDI BID for 14 days

Participant Flow: Overall Study

	MF/F MDI 100/10 Mcg	MF/F MDI 200/10 Mcg	MF/F MDI 400/10 Mcg	MF DPI 200 Mcg	MF MDI 200 Mcg	Placebo
STARTED	20	17	12	15	16	13
COMPLETED	19	17	12	15	16	13
NOT COMPLETED	1	0	0	0	0	0
Protocol Violation	1	0	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
MF/F MDI 100/10 Mcg	Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
MF/F MDI 200/10 Mcg	MF/F MDI 200/10 mcg BID for 14 days
MF/F MDI 400/10 Mcg	MF/F MDI 400/10 mcg BID for 14 days
MF DPI 200 Mcg	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
MF MDI 200 Mcg	MF MDI 200 mcg BID for 14 days
Placebo	Placebo MDI BID for 14 days

Baseline Measures

	MF/F MDI 100/10 Mcg	MF/F MDI 200/10 Mcg	MF/F MDI 400/10 Mcg	MF DPI 200 Mcg	MF MDI 200 Mcg	Placebo	Total
Number of Participants [units: participants]	20	17	12	15	16	13	93
Age, Customized [units: participants]
18 to <65 years	20	14	11	15	16	11	87
> or = to 65 years	0	3	1	0	0	2	6
Gender [units: participants]
Female	13	10	4	6	6	8	47
Male	7	7	8	9	10	5	46

Outcome Measures

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1. Primary:

Mean Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb) [ Time Frame: Baseline to Day 14 ]

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2. Secondary:

Mean Percent Change From Baseline to Day 7 in eNO Ppb [ Time Frame: Baseline to Day 7 ]

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3. Secondary:

Mean Percent Change From Baseline to Day 14 in Sputum Eosinophil Count (Percentage) [ Time Frame: Baseline to Day 14 ]

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4. Secondary:

Mean Change From Baseline to Day 15 of Mannitol Challenge [ Time Frame: Baseline to Day 15 ]

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5. Secondary:

Change From Baseline in AM Total Asthma Symptom Score at Days 2-15 [ Time Frame: Baseline and Days 2-15 ]

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6. Secondary:

Change From Baseline in PM Total Asthma Symptom Score at Days 1-15 [ Time Frame: Baseline and Days 1-15 ]

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7. Secondary:

Change From Baseline in AM Peak Expiratory Flow (PEF) at Days 2-15 [ Time Frame: Baseline and Days 2-15 ]

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8. Secondary:

Change From Baseline in PM PEF at Days 1-15 [ Time Frame: Baseline and Days 1-15 ]

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9. Other Pre-specified:

Baseline Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb) [ Time Frame: Baseline ]

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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:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00635882 History of Changes
Other Study ID Numbers:	P05122
Study First Received:	January 21, 2008
Results First Received:	October 22, 2010
Last Updated:	February 10, 2011
Health Authority:	United States: Food and Drug Administration