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

Completed · Phase 2

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01691612

Run by

Brigham and Women's Hospital

People needed

14

Starts

2013-03-01

Expected to finish

2015-05-01

Last updated by the study team

2017-07-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Asthma Research Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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