A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)(COMPLETED)

This study has been completed.

Study NCT00442117 Information provided by Schering-Plough

First Received on February 28, 2007. Last Updated on March 24, 2011 History of Changes

Results First Received: January 12, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: mometasone furoate dry powder inhaler Drug: Budesonide DPI

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
A total of 180 participants were enrolled and randomized. There were 8 participants who had taken at least one dose of study medication, but were not eligible for the study and therefore were withdrawn, resulting in the Intent-to-Treat (ITT) population of 172 participants.

Reporting Groups

	Description
MF-DPI	Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
BUD-DPI	Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)

Participant Flow: Overall Study

	MF-DPI	BUD-DPI
STARTED	85	87
COMPLETED	47	49
NOT COMPLETED	38	38
Adverse Event	3	2
Lack of Efficacy	2	6
Lost to Follow-up	1	2
Withdrawal by Subject	2	2
Major Deviation	25	20
Non compliance with protocol	3	5
Met Withdrawal Criteria	2	1

Baseline Characteristics

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Reporting Groups

	Description
MF-DPI	Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
BUD-DPI	Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)

Baseline Measures

	MF-DPI	BUD-DPI	Total
Number of Participants [units: participants]	91	89	180
Age, Customized ^[1] [units: participants]
>=12 years	91	89	180
Gender ^[1] [units: participants]
Female	48	40	88
Male	43	49	92

[1]	Number of participants analyzed includes data of the total enrolled population

Outcome Measures

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1. Primary:

Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12. [ Time Frame: Baseline and Week 12 ]

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2. Secondary:

Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12. [ Time Frame: Baseline and Week 12 ]

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3. Secondary:

Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12. [ Time Frame: Baseline and Week 12 ]

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4. Secondary:

Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12. [ Time Frame: Baseline and 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 NOT 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.

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 and Dohme Corp
e-mail: ClinicalTrialsDisclcosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00442117 History of Changes
Other Study ID Numbers:	P04880
Study First Received:	February 28, 2007
Results First Received:	January 12, 2011
Last Updated:	March 24, 2011
Health Authority:	Taiwan: Department of Health