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Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00383240
First received: September 29, 2006
Last updated: February 10, 2011
Last verified: February 2011
History of Changes
Results First Received: June 30, 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: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID
Drug: Mometasone furoate MDI (MF MDI) 200 mcg
Drug: formoterol fumarate 10 mcg
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
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Reporting Groups
  Description
MF/F MDI 200/10 Mcg BID mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
MF MDI 200 Mcg BID Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
F MDI 10 Mcg BID Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
Placebo BID Placebo MDI BID for 26 weeks

Participant Flow:   Overall Study
    MF/F MDI 200/10 Mcg BID     MF MDI 200 Mcg BID     F MDI 10 Mcg BID     Placebo BID  
STARTED     191     192     202     196  
COMPLETED     156     159     117     119  
NOT COMPLETED     35     33     85     77  
Adverse Event                 4                 6                 9                 7  
Treatment Failure                 8                 13                 47                 46  
Lost to Follow-up                 3                 0                 0                 2  
Withdrawal by subject, reasons unrelated                 6                 3                 8                 8  
Withdrawal by subjects, reasons related                 0                 1                 3                 5  
Protocol Violation                 4                 5                 9                 6  
Did not meet protocol eligibility                 9                 4                 9                 3  
Administrative                 1                 1                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
MF/F MDI 200/10 Mcg BID mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
MF MDI 200 Mcg BID Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
F MDI 10 Mcg BID Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
Placebo BID Placebo MDI BID for 26 weeks
Total Total of all reporting groups

Baseline Measures
    MF/F MDI 200/10 Mcg BID     MF MDI 200 Mcg BID     F MDI 10 Mcg BID     Placebo BID     Total  
Number of Participants  
[units: participants]
 		  191     192     202     196     781  
Age  
[units: participants]
 		         
<=18 years     19     10     18     16     63  
Between 18 and 65 years     161     173     174     169     677  
>=65 years     11     9     10     11     41  
Age  
[units: years]
Mean ± Standard Deviation 		  42.9  ± 16.3     42.8  ± 14.9     41.9  ± 15.3     41.9  ± 15.3     42.4  ± 15.4  
Gender  
[units: participants]
 		         
Female     97     112     129     122     460  
Male     94     80     73     74     321  



  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 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF   [ Time Frame: Baseline to Endpoint (12 weeks) ]
  Show Outcome Measure 1

2.  Primary:   Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F   [ Time Frame: 26-week Treatment Period ]
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3.  Secondary:   Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score   [ Time Frame: Baseline to Week 26 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score   [ Time Frame: Baseline to week 26 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA)   [ Time Frame: Baseline to Endpoint ]
  Show Outcome Measure 5

6.  Other Pre-specified:   Number of Participants With at Least One Severe Asthma Exacerbation   [ Time Frame: Baseline to Week 26 ]
  Show Outcome Measure 6


  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:
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.
unchecked 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: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided by Schering-Plough

Publications automatically indexed to this study:


Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00383240     History of Changes
Other Study ID Numbers: P04334, EUDRACT No.: 2006-001578-25;
Study First Received: September 29, 2006
Results First Received: June 30, 2010
Last Updated: February 10, 2011
Health Authority: United States: Food and Drug Administration