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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
September 7, 2012
September 25, 2012
March 6, 2017
July 3, 2017
July 3, 2017
March 2013
May 2015   (Final data collection date for primary outcome measure)
Change From Baseline in the Percentage of Total White Blood Cell That Were Eosinophils at 48 Hours [ Time Frame: from baseline to 48 hours ]

Measure Pin1 activity in BAL-derived eosinophils after House Dust Mite (HDM) allergen challenge:

Eosinophils post-challenge change from pre-challenge is reported: absolute change = [eosinophils post (%) - eosinophils pre (%)]

Pin1 enzyme activation in BAL-derived eosinophils [ Time Frame: 48 hours ]
We will measure Pin1 activity in BAL-derived eosinophils after House Dust Mite (HDM) allergen challenge.
Complete list of historical versions of study NCT01691612 on ClinicalTrials.gov Archive Site
  • 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 ]
    Percent change in percentage of total white blood cell that were lymphocytes is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]
  • 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 ]
    Percent change in percentage of total white blood cell that were macrophages is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]
  • Change From Baseline in the Percentage of Total White Blood Cell That Were Neutrophils at 48 Hours [ Time Frame: from baseline to 48 hours ]
    Neutrophils have some zero values pre-challenge, so absolute change is reported instead of percent change: post-pre from baseline to 48 hours
Not Provided
Not Provided
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Role of the Isomerase Pin-1 in the Development and Treatment of Asthma
Role of the Isomerase Pin-1 in the Development and Treatment of Asthma
Pin1 is activated in asthmatic airways, increasing cytokine mRNA stability and eosinophil survival. This study is designed to test whether the Pin1 enzyme regulates TLR/IL-1R signal pathways in multiple cells in asthma.
The investigators will test their hypothesis that Pin1 regulates TLR/IL-1R signaling pathways in asthma by examining Pin1 and related pathway activation in BAL-derived eosinophils after house dust mite allergen challenge. The investigators will perform segmental allergen challenge. BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later and activation of Pin1 and related pathways will be examined.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Asthma
Biological: 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
Other Name: D. pteronyssinus allergens exposure
Experimental: 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
Intervention: Biological: installation of D. pteronyssinus allergens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
May 2015
May 2015   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Subjects 18-55 years of age, diagnosed with asthma for at least 1 year;
  • And FEV1 > 70% predicted on only short acting beta agonists e.g albuterol
  • And methacholine PC20 < 8 mg/ml
  • Positive skin prick test to Dermatophagoides pteronyssinus(DerP)
  • No prior history of intubation for asthma
  • No use of inhaled corticosteroids for 1 month prior to entry

Exclusion criteria:

  • Current smoking or smoking history of greater than 10 pack-years
  • Any other clinically important comorbidity determined by the principal investigator to affect subject safety, including uncontrolled diabetes, uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension that would increase the risk of significant adverse events during bronchoscopy,
  • Worsening of asthma symptoms requiring treatment with steroids within 4 weeks of screening
  • Respiratory infection within four weeks
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant or who are currently pregnant or lactating.

Unless they:

  • Are women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
  • Are women whose partners have been sterilized by vasectomy or other means
  • Use one acceptable birth control method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
  • Pre-existing lung disease other than asthma
  • History of coagulation disorders or abnormal PT/PTT testing at screening
  • History of immunodeficiency diseases, including HIV
  • A disability that may prevent the patient from completing all study requirements
  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  • Diagnosis of Hepatitis B or C.
  • History of alcohol abuse (as determined by the principal investigator) within 6 months of screening.
  • History of illicit drug abuse (as determined by the principal investigator) within 6 months of screening.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01691612
2012P001029
No
Not Provided
Not Provided
Elliot Israel, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Kun P Lu, M.D., PhD Beth Israel Deaconess Medical Center
Principal Investigator: Elliot Israel, M.D Brigham and Womens Hospital
Brigham and Women's Hospital
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP