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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00383721
First received: September 29, 2006
Last updated: October 14, 2013
Last verified: October 2013
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
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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
  Show All Outcome Measures

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) ]

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

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

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) ]

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

6.  Secondary:   Number of Participants With Mild, Moderate, or Severe COPD Exacerbations   [ Time Frame: Endpoint (26 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  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:
unchecked 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.
unchecked 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.


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
No text entered.  


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 Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: 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: October 14, 2013
Health Authority: United States: Food and Drug Administration