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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)
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00442351
First received: February 28, 2007
Last updated: March 26, 2010
Last verified: March 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
Total Total of all reporting groups

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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