Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED)

This study has been terminated.

( Slow Enrollment )

Study NCT00442351 Information provided by Schering-Plough

First Received on February 28, 2007. Last Updated on March 26, 2010 History of Changes

Results First Received: March 26, 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: Asmanex twisthaler Other: Placebo for Asmanex twisthaler

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
Asmanex Twisthaler	Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
Placebo Inhaler	Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks

Participant Flow: Overall Study

	Asmanex Twisthaler	Placebo Inhaler
STARTED	17 ^[1]	9
COMPLETED	10	3
NOT COMPLETED	7	6
Administrative	6	5
Did not meet protocol eligibility	1	0
Not specified	0	1

[1]	Due to poor enrollment and a high screening failure rate, this study was terminated early.

Baseline Characteristics

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Reporting Groups

	Description
Asmanex Twisthaler	Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
Placebo Inhaler	Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks

Baseline Measures

	Asmanex Twisthaler	Placebo Inhaler	Total
Number of Participants [units: participants]	17	9	26
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	17	8	25
>=65 years	0	1	1
Age [units: years] Mean ± Standard Deviation	41.9 ± 11.9	42.6 ± 17.0	42.1 ± 13.5
Gender [units: participants]
Female	10	7	17
Male	7	2	9
Region of Enrollment [units: participants]
United States	17	9	26

Outcome Measures

1. Primary:

Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements. [ Time Frame: Twelve (12) weeks ]

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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 PI is not allowed to release any interim results of the Study without prior consent of the sponsor, and must provide 45 days written notice to the sponsor prior to public release to permit the sponsor's review. The PI can use the study results for his/her own teaching, research, and publication purposes only, not for commercial purposes, except as authorized by the sponsor. No publication shall contain any trade secret or proprietary/confidential information of the sponsor.

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
This study was terminated early due to a high screening failure rate and poor enrollment that resulted from stringent inclusion and exclusion criteria. Efficacy data were not evaluated.

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:	NCT00442351 History of Changes
Other Study ID Numbers:	P04654, IND Number: 46216; SCH 032088
Study First Received:	February 28, 2007
Results First Received:	March 26, 2010
Last Updated:	March 26, 2010
Health Authority:	United States: Food and Drug Administration