The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726AM2)(COMPLETED)

This study has been completed.

Study NCT00359216 Information provided by Schering-Plough

First Received on July 31, 2006. Last Updated on May 21, 2010 History of Changes

Results First Received: January 23, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Perennial Allergic Rhinitis Obstructive Sleep Apnea Sleep Disorder
Interventions:	Drug: Mometasone furoate nasal spray 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
There was a screening period followed by a 7-day run-in period, followed by the treatment period.

Reporting Groups

	Description
Mometasone Furoate Nasal Spray	100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
Placebo Nasal Spray	The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.

Participant Flow: Overall Study

	Mometasone Furoate Nasal Spray	Placebo Nasal Spray
STARTED	20	10
COMPLETED	20	9 ^[1]
NOT COMPLETED	0	1

[1]	Completed treatment but simultaneously partaking in other study,final study procedures not performed

Baseline Characteristics

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Reporting Groups

	Description
Mometasone Furoate Nasal Spray	100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
Placebo Nasal Spray	The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.

Baseline Measures

	Mometasone Furoate Nasal Spray	Placebo Nasal Spray	Total
Number of Participants [units: participants]	20	10	30
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	20	10	30
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	34.55 ± 10.11	33.70 ± 8.11	34.27 ± 9.36
Gender [units: participants]
Female	12	4	16
Male	8	6	14

Outcome Measures

1. Primary:

Apnea-Hypopnea Index [ Time Frame: change from baseline (screening) at the end of 28 days 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.

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: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00359216 History of Changes
Other Study ID Numbers:	P04726
Study First Received:	July 31, 2006
Results First Received:	January 23, 2009
Last Updated:	May 21, 2010
Health Authority:	United States: Food and Drug Administration