Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in Chronic Obstructive Pulmonary Disease (COPD) (Study P04230AM4)(COMPLETED)

This study has been completed.

Sponsor:

Collaborator:

Novartis

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00383721

First received: September 29, 2006

Last updated: September 16, 2011

Last verified: September 2011

History of Changes

Results First Received: July 22, 2011

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:	Chronic Obstructive Pulmonary Disease (COPD)
Interventions:	Drug: Mometasone furoate/formoterol (MF/F) combination Drug: Mometasone furoate MDI (MF MDI) Drug: Formoterol MDI 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
At Week 26, all participants randomized to placebo were to be discontinued, while 75% of participants randomized to an active treatment were randomly selected to participate in the 26-week Treatment Safety Extension. Several placebo-treated participants continued in error into the Treatment Safety Extension.

Reporting Groups

	Description
MF/F MDI 400/10 Mcg BID	Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
MF/F MDI 200/10 Mcg BID	MF/F 200/10 mcg via a MDI BID for 52 weeks.
MF MDI 400 Mcg BID	Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
F MDI 10 Mcg BID	Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
Placebo	Placebo MDI BID for 26 weeks.

Participant Flow for 2 periods

Period 1: 26-Week Double-Blind Treatment Period

	MF/F MDI 400/10 Mcg BID	MF/F MDI 200/10 Mcg BID	MF MDI 400 Mcg BID	F MDI 10 Mcg BID	Placebo
STARTED	225	239	253	243	236
COMPLETED	190 ^[1]	202	202	193	169
NOT COMPLETED	35	37	51	50	67
Adverse Event	11	5	7	14	13
Lack of Efficacy	1	3	3	4	8
Lost to Follow-up	0	0	2	1	4
Participant withdrawal unrelated	4	12	15	10	11
Participant withdrawal related	5	3	6	8	9
Non-compliance with protocol	7	5	4	6	6
Did not meet protocol eligibility	5	6	11	4	13
Administrative	1	3	3	3	3
Ongoing	1	0	0	0	0

[1]	1 participant listed as “ongoing” since the participant status could not be formally confirmed.

Period 2: 26-Week Treatment Safety Extension

	MF/F MDI 400/10 Mcg BID	MF/F MDI 200/10 Mcg BID	MF MDI 400 Mcg BID	F MDI 10 Mcg BID	Placebo
STARTED	145	153	149	148	8
COMPLETED	126	136	126	131	8
NOT COMPLETED	19	17	23	17	0
Adverse Event	6	7	10	1	0
Lack of Efficacy	0	2	4	1	0
Lost to Follow-up	2	0	1	1	0
Participant withdrawal unrelated	6	4	2	7	0
Participant withdrawal related	1	1	1	1	0
Non-compliance with protocol	2	1	1	4	0
Did not meet protocol eligibility	1	0	1	1	0
Administrative	1	2	3	1	0

Baseline Characteristics

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Reporting Groups

	Description
MF/F MDI 400/10 Mcg BID	Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
MF/F MDI 200/10 Mcg BID	MF/F 200/10 mcg via a MDI BID for 52 weeks.
MF MDI 400 Mcg BID	Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
F MDI 10 Mcg BID	Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
Placebo	Placebo MDI BID for 26 weeks.
Total	Total of all reporting groups

Baseline Measures

	MF/F MDI 400/10 Mcg BID	MF/F MDI 200/10 Mcg BID	MF MDI 400 Mcg BID	F MDI 10 Mcg BID	Placebo	Total
Number of Participants [units: participants]	225	239	253	243	236	1196
Age [units: years] Mean ± Standard Deviation	59.2 ± 9.1	60.1 ± 9.0	60.5 ± 8.5	59.7 ± 8.7	58.8 ± 9.5	59.7 ± 9.0
Gender [units: participants]
Female	57	64	56	61	58	296
Male	168	175	197	182	178	900

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 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) [ Time Frame: Baseline to Endpoint (13 weeks) ]

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2. Primary:

Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 [ Time Frame: Baseline to Endpoint (13 weeks) ]

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3. Secondary:

Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score [ Time Frame: Baseline to Endpoint (26 weeks) ]

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4. Secondary:

Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms) [ Time Frame: Baseline to Endpoint (26 weeks) ]

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5. Secondary:

Number of Participants With Partly Stable COPD [ Time Frame: Endpoint (26 weeks) ]

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6. Secondary:

Number of Participants With Mild, Moderate, or Severe COPD Exacerbations [ Time Frame: Endpoint (26 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 investigator has the right to publish or publicly present results. The investigator agrees not to publish or publicly present any interim results without prior written consent of the sponsor. The investigator agrees to provide to the sponsor 45 days before submission for publication that report results of the study. The sponsor shall have the right to review & comment with respect to publications, abstracts, slides, & manuscripts & the right to review & comment on the data & presentation.

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, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided by Schering-Plough

Publications automatically indexed to this study:

Tashkin DP, Doherty DE, Kerwin E, Matiz-Bueno CE, Knorr B, Shekar T, Gates D, Staudinger H. Efficacy and safety characteristics of mometasone furoate/formoterol fumarate fixed-dose combination in subjects with moderate to very severe COPD: findings from pooled analysis of two randomized, 52-week placebo-controlled trials. Int J Chron Obstruct Pulmon Dis. 2012;7:73-86. Epub 2012 Feb 3.

Doherty DE, Tashkin DP, Kerwin E, Knorr BA, Shekar T, Banerjee S, Staudinger H. Effects of mometasone furoate/formoterol fumarate fixed-dose combination formulation on chronic obstructive pulmonary disease (COPD): results from a 52-week Phase III trial in subjects with moderate-to-very severe COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:57-71. Epub 2012 Feb 3.

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00383721 History of Changes
Other Study ID Numbers:	P04230, Doc ID: 3227335,, Eudract No: 2006-002309-30,
Study First Received:	September 29, 2006
Results First Received:	July 22, 2011
Last Updated:	September 16, 2011
Health Authority:	United States: Food and Drug Administration

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