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A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma

This study has been terminated.
(by sponsor due to failure to recruit patients who had mild persistent asthma who were not already on Advair 250/50 or 500/50.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461812
First Posted: April 18, 2007
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: August 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single;   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Mometasone
Drug: Advair

  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
33 participants were consented for this study. However, there were 23 pre-randomization screening failures. Only 10 were enrolled. The number of participants assigned/randomized to each Arm/Group is unknown.

Reporting Groups
  Description
All Participants

Mometasone

or

Advair


Participant Flow:   Overall Study
    All Participants
STARTED   10 
COMPLETED   0 
NOT COMPLETED   10 
study terminated                10 



  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.
The number of participants assigned/randomized to each Arm/Group is unknown

Reporting Groups
  Description
All Participants

Mometasone

or

Advair


Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age, Customized 
[Units: Participants]
Count of Participants
 
>=18, <=16 years   10 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  60.0% 
Male      4  40.0% 
Region of Enrollment 
[Units: Participants]
 
United States   10 


  Outcome Measures

1.  Primary:   Efficacy as Assessed my Pulmonary Function Tests   [ Time Frame: change from baseline to study completion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Johns Hopkins University Clinical Trials Program
Organization: Johns Hopkins University School of Medicine
phone: 410-550-6484
e-mail: registerclinicaltrials@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00461812     History of Changes
Other Study ID Numbers: NA_00001154
First Submitted: April 16, 2007
First Posted: April 18, 2007
Results First Submitted: August 14, 2017
Results First Posted: September 20, 2017
Last Update Posted: September 20, 2017