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Role of the Isomerase Pin-1 in the Development and Treatment of Asthma (Pin1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01691612
First Posted: September 25, 2012
Last Update Posted: July 3, 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.
Information provided by (Responsible Party):
Elliot Israel, MD, Brigham and Women's Hospital
Results First Submitted: March 6, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Asthma
Intervention: Biological: installation of D. pteronyssinus allergens

  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
D. Pteronyssinus Allergens

Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments

installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later


Participant Flow:   Overall Study
    D. Pteronyssinus Allergens
STARTED   14 
First Visit (Allergen Challenge)   8 
Second Visit (Bronchoscopy)   7 
COMPLETED   7 
NOT COMPLETED   7 
deemed ineligible after 1st visit                6 
Adverse Event                1 



  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
D. Pteronyssinus Allergens

Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments

installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later


Baseline Measures
   D. Pteronyssinus Allergens 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      8 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 24.9  (3.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  50.0% 
Male      4  50.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1  12.5% 
Not Hispanic or Latino      7  87.5% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1  12.5% 
White      6  75.0% 
More than one race      1  12.5% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   8 


  Outcome Measures
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1.  Primary:   Change From Baseline in the Percentage of Total White Blood Cell That Were Eosinophils at 48 Hours   [ Time Frame: from baseline to 48 hours ]

2.  Secondary:   Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Lymphocytes at 48 Hours   [ Time Frame: from baseline to 48 hours ]

3.  Secondary:   Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Macrophages at 48 Hours   [ Time Frame: from baseline to 48 hours ]

4.  Secondary:   Change From Baseline in the Percentage of Total White Blood Cell That Were Neutrophils at 48 Hours   [ Time Frame: from baseline to 48 hours ]


  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: Elliot Israel, M.D.
Organization: Brigham & Women's Hospital
phone: 617-732-8110
e-mail: eisrael@partners.org



Responsible Party: Elliot Israel, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01691612     History of Changes
Other Study ID Numbers: 2012P001029
First Submitted: September 7, 2012
First Posted: September 25, 2012
Results First Submitted: March 6, 2017
Results First Posted: July 3, 2017
Last Update Posted: July 3, 2017