Abstract

This is a randomized, multi-center, double-blind, single dose, placebo-controlled, dose escalating study of recombinant IL-12. Patients will be randomized to either IL-12 or placebo in a 4 to 1 ratio: Four cohorts of 10 patients will be entered. Patients must have a history of hyper-responsive airways to be eligible for this study. The primary objective of this study is to assess safety and tolerability of IL-12: a secondary objective is to assess the effects of IL-12 on the patients' baseline airway reactivity by evaluating pre- and post-dose methacholine PC20. This study is based upon the hypothesis that cytokines induced by T helper cells type 2 contributed to the physiological changes associated with asthma while cytokines produced by T helper cells type 1 antagonize these effects. IL-12 facilitates development of T helper type 1 cell differentiation and blocks the differentiation of T helper cell type 2. This is the first clinical study of IL-12 in patients with known airway hyperresponsiveness.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR003186-15
Application #
6413051
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1994-12-01
Project End
2004-11-30
Budget Start
Budget End
Support Year
15
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
University of Wisconsin Madison
Department
Type
DUNS #
161202122
City
Madison
State
WI
Country
United States
Zip Code
53715

  Publications

Burgess-Hull, Albert J; Roberts, Linda J; Piper, Megan E et al. (2018) The social networks of smokers attempting to quit: An empirically derived and validated classification. Psychol Addict Behav 32:64-75
Kelly, Elizabeth A; Esnault, Stephane; Liu, Lin Ying et al. (2017) Mepolizumab Attenuates Airway Eosinophil Numbers, but Not Their Functional Phenotype, in Asthma. Am J Respir Crit Care Med 196:1385-1395
Shen, Zhong-Jian; Hu, Jie; Kashi, Venkatesh P et al. (2017) Epstein-Barr Virus-induced Gene 2 Mediates Allergen-induced Leukocyte Migration into Airways. Am J Respir Crit Care Med 195:1576-1585
Anderson, Halie M; Lemanske Jr, Robert F; Evans, Michael D et al. (2017) Assessment of wheezing frequency and viral etiology on childhood and adolescent asthma risk. J Allergy Clin Immunol 139:692-694
Gomez, Jose L; Yan, Xiting; Holm, Carole T et al. (2017) Characterisation of asthma subgroups associated with circulating YKL-40 levels. Eur Respir J 50:
Kelly, Elizabeth A; Esnault, Stephane; Johnson, Sean H et al. (2016) Human eosinophil activin A synthesis and mRNA stabilization are induced by the combination of IL-3 plus TNF. Immunol Cell Biol 94:701-8
Bray, Bethany C; Smith, Rachel A; Piper, Megan E et al. (2016) Transitions in Smokers' Social Networks After Quit Attempts: A Latent Transition Analysis. Nicotine Tob Res 18:2243-2251
Dougherty, Ryan J; Ellingson, Laura D; Schultz, Stephanie A et al. (2016) Meeting physical activity recommendations may be protective against temporal lobe atrophy in older adults at risk for Alzheimer's disease. Alzheimers Dement (Amst) 4:14-7
Johansson, Mats W; Evans, Michael D; Crisafi, Gina M et al. (2016) Serum periostin is associated with type 2 immunity in severe asthma. J Allergy Clin Immunol 137:1904-1907.e2
Lee, Yong Gyu; Jeong, Jong Jin; Nyenhuis, Sharmilee et al. (2015) Recruited alveolar macrophages, in response to airway epithelial-derived monocyte chemoattractant protein 1/CCl2, regulate airway inflammation and remodeling in allergic asthma. Am J Respir Cell Mol Biol 52:772-84

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