Role of the Isomerase Pin-1 in the Development and Treatment of Asthma (Pin1)
Verified February 2015 by Brigham and Women's Hospital
Information provided by (Responsible Party):
Elliot Israel, MD, Brigham and Women's Hospital
First received: September 7, 2012
Last updated: February 18, 2015
Last verified: February 2015
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.
Biological: installation of D. pteronyssinus allergens
||Intervention Model: Single Group Assignment
Masking: Open Label
||Role of the Isomerase Pin-1 in the Development and Treatment of Asthma
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
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
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
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.
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691612
|Asthma Research Center
|Boston, Massachusetts, United States, 02115 |
|Contact: Allison Crosby-Thompson 617-525-8034 firstname.lastname@example.org |
|Contact: Kyle F Nelson 617-732-8630 email@example.com |
|Principal Investigator: Elliot Israel, M.D |
|Sub-Investigator: Shamsah Kazani, M.D., MMSc |
Brigham and Women's Hospital
||Kun P Lu, M.D., PhD
||Beth Israel Deaconess Medical Center
||Elliot Israel, M.D
||Brigham and Womens Hospital
No publications provided
||Elliot Israel, MD, Physician, Brigham and Women's Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 7, 2012
||February 18, 2015
||United States: Food and Drug Administration
Keywords provided by Brigham and Women's Hospital:
Role of Pin-1 enzyme in Asthma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 30, 2015
Immune System Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases