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Role of Eosinophils in the Proliferation of Airway Smooth Muscle (ASM) Cells

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082952
First Posted: March 9, 2010
Last Update Posted: November 18, 2011
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.
Information provided by (Responsible Party):
Saleh Zaid Al-Muhsen, King Saud University
Results First Submitted: July 20, 2011  
Study Type: Observational
Study Design: Observational Model: Case Control
Condition: Asthma

  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
recruitment started January 2010 and ended July 2011. Recruitment was all in King Khalid Hospital, Riyadh, Saudi Arabia

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
Asthmatic Patients Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
Non Asthmatic Patients Non asthmatic patients with high eosinophil count (>3%).

Participant Flow:   Overall Study
    Asthmatic Patients   Non Asthmatic Patients
STARTED   6   6 
COMPLETED   6   6 
NOT COMPLETED   0   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.
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Reporting Groups
  Description
Asthmatic Patients Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
Non Asthmatic Patients Non asthmatic patients with high eosinophil count (>3%).
Total Total of all reporting groups

Baseline Measures
   Asthmatic Patients   Non Asthmatic Patients   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Participants]
     
<=18 years   2   1   3 
Between 18 and 65 years   4   5   9 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 23  (3)   24  (2.5)   23.5  (2.75) 
Gender 
[Units: Participants]
     
Female   2   1   3 
Male   4   5   9 
Region of Enrollment 
[Units: Participants]
     
Saudi Arabia   6   6   12 


  Outcome Measures
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1.  Primary:   Fold Increase in ASM Proliferation Following Incubation With Eosinophils.   [ Time Frame: one day ]

2.  Secondary:   Fold Increase in ASM Cells Proliferation Following Treatment With Cysteinyl Leukotrienes   [ Time Frame: one day ]


  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
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  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: Dr. Rabih Halwani
Organization: King Saud University
phone: 00966551307134
e-mail: rhalwani@ksu.edu.sa



Responsible Party: Saleh Zaid Al-Muhsen, King Saud University
ClinicalTrials.gov Identifier: NCT01082952     History of Changes
Other Study ID Numbers: effect of eosinophil on ASM
First Submitted: March 8, 2010
First Posted: March 9, 2010
Results First Submitted: July 20, 2011
Results First Posted: November 18, 2011
Last Update Posted: November 18, 2011