Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED)

This study has been completed.

Study NCT00383552 Information provided by Schering-Plough

First Received on September 29, 2006. Last Updated on September 16, 2011 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: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID Drug: Mometasone Furoate MDI (MF MDI) Drug: Formoterol Fumarate 10 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 BID	Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
MF MDI 100 Mcg BID	Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
F MDI 10 Mcg BID	Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
Placebo BID	Placebo twice daily (BID)

Participant Flow: Overall Study

	MF/F MDI 100/10 Mcg BID	MF MDI 100 Mcg BID	F MDI 10 Mcg BID	Placebo BID
STARTED	182	188	188	188
COMPLETED	146	147	127	116
NOT COMPLETED	36	41	61	72
Adverse Event	7	6	9	6
Lack of Efficacy	4	13	29	42
Lost to Follow-up	0	1	5	1
Did not wish to continue (unrelated)	4	9	5	6
Did not wish to continue (related)	1	0	2	3
Noncompliance with the protocol	11	6	8	10
Did not meet protocol eligibility	8	6	2	3
Administrative	1	0	1	1

Baseline Characteristics

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Reporting Groups

	Description
MF/F MDI 100/10 Mcg BID	Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
MF MDI 100 Mcg BID	Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
F MDI 10 Mcg BID	Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
Placebo BID	Placebo twice daily (BID)

Baseline Measures

	MF/F MDI 100/10 Mcg BID	MF MDI 100 Mcg BID	F MDI 10 Mcg BID	Placebo BID	Total
Number of Participants [units: participants]	182	188	188	188	746
Age [units: years] Mean ± Standard Deviation	37.1 ± 16.9	39.4 ± 16.7	38.5 ± 15.6	38.1 ± 17.4	38.3 ± 16.6
Gender [units: participants]
Female	99	105	103	106	413
Male	83	83	85	82	333

Outcome Measures

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1. Primary:

Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) [ Time Frame: Baseline to Week 12 ]

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2. Primary:

Median Time-to-first Severe Asthma Exacerbation Over the 26-week Treatment Period [ Time Frame: Across the 26 week treatment period ]

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3. Primary:

Number of Participants With at Least One Severe Asthma Exacerbation at Week 26 [ Time Frame: Week 26 ]

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4. Secondary:

Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Total Score [ Time Frame: Baseline to Week 26 ]

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5. Secondary:

Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standarized Activities (AQLQ[S]) Total Score [ Time Frame: Baseline to Week 26 ]

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6. Secondary:

Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta Agonists (SABA) [ Time Frame: Baseline to Endpoint ]

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7. Secondary:

Change From Baseline in AM FEV1 Pre-dose Assessment, or Trough FEV1, at Week 12 [ Time Frame: Baseline to Week 12 ]

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8. Secondary:

AUC(0-12 Hour) of the Change From Baseline to Week 12 in FEV1 for Each Body Mass Index (BMI) Subgroup [ Time Frame: Baseline to Week 12 ]

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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:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00383552 History of Changes
Other Study ID Numbers:	P04073, Doc ID: 3100873;, EUDRACT No: 2006-001577-13;
Study First Received:	September 29, 2006
Results First Received:	July 15, 2010
Last Updated:	September 16, 2011
Health Authority:	United States: Food and Drug Administration