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Allergy Clinical Research Unit

The Allergy Clinical Research Unit conducts clinical "translational" research and drug trials of allergic and immunologic diseases, including asthma, chronic rhinosinusitis, nasal polyopsis, drug allergy, hereditary angioedema (HAE) and food allergy.
  • Phone: 617-726-6376

The Allergy Clinical Research Unit (ACRU) at Massachusetts General Hospital (MGH) was established in October 2003 and is directed by Daniel Hamilos MD.  It is located in the Cox Building, 2nd floor at MGH.  It is staffed by full-time study coordinator(s).  Each coordinator is responsible for 3-5 active clinical trials.  The coordinators recruit and screen subjects for studies of asthma, chronic rhinosinusitis, nasal polyposis, drug allergy, hereditary angioedema and food allergy.  

A major focus of the ACRU is "translational research", i.e. research that applies advanced laboratory techniques to the study of human allergic diseases.  This allows the researchers to investigate disease at its most fundamental level.  Examples of studies include: (1) a study of inflammatory cell (lymphocyte) movement into the lungs during an asthma attack, (2) a study that seeks to identify weaknesses in "local immunity" in sinus tissue that may cause chronic rhinosinusitis.  The ACRU also studies novel drug treatments.  Examples include: (1) a study of purified C1 Esterase Inhibitor as a treatment for hereditary angioedema (HAE), and (2) a study of omalizumab as a treatment for polypoid chronic rhinosinusitis.

The ACRU conducts approximately 150 research subject visits per year.   Procedures done in the unit include: physical examinations, allergy skin testing, blood drawing, urine pregnancy tests, pulmonary function testing (spirometry) before and after bronchodilator, methacholine bronchial challenges, bronchoscopy with segmental allergen challenge, sinus rhinoscopic assessments and sinus CT scanning.

Studies currently recruiting:

  • Asthma
  • Chronic rhinosinusitis (with and without nasal polyposis)
  • Drug allergy
  • Food allergy
  • Hereditary angioedema (HAE)
  • Nasal polyposis

NIH-sponsored Asthma study

Inflammatory Cellular Trafficking in Asthma in Response to Segmental Allergen Challenge

Andrew D. Luster, M.D., Ph.D., Principal Investigator; Daniel L. Hamilos, Co-Investigator

The goal of this study is to identify the mediators and inflammatory cell surface receptors involved in allergic airway inflammation.  This goal is being accomplished by comparing chemokine ligands and receptor expression on inflammatory cells, including lymphocytes, in airway tissue and peripheral blood before and after segmental allergen challenge in subjects with allergic asthma.  Allergic asthmatics are being compared to healthy nonallergic subjects and nonasthmatic subjects with allergic rhinitis. 

Each subject in this study undergoes:  allergy skin testing, blood drawing, urine pregnancy tests (females), pulmonary function testing by spirometry pre and post bronchodilator, a methacholine bronchial challenge test and bronchoscopy with segmental allergen challenge.

 

The FAMRI Study

Pathogenesis of Chronic Sinusitis in Relationship to Tobacco Smoke Exposure 

Daniel L. Hamilos, M.D., Principal Investigator

The overall goal of this study is to understand the mechanisms of persistent inflammation in chronic rhinosinusitis (CRS) and the role of secondhand cigarette smoke (SS) in this process.  We are focusing on "epithelial innate immunity", i.e. the role of the sinus epithelium in defending against bacterial infection and in signaling the immune system to fight infection. 

This study involves allergy skin testing, nasal examination by rhinoscopy, nasal turbinate or nasal polyp biopsies, culturing nasal epithelial cells and studying their response to cigarette smoke as well as other factors that mimic a bacterial infection. 

 

The FAMRI substudy (Catalyst award)

The Relationship Between Defects in Mucosal Innate Immunity and Abnormalities in the Microbial Community of Patients with Refractory Chronic Rhinosinusitis 

Daniel L. Hamilos, M.D., Principal Investigator

This is a substudy of the FAMRI study in which we are focusing on the most "refractory" cases of chronic rhinosinusitis (CRS).  Each patient involved in this study undergoes a clinical evaluation, including allergy skin testing, rhinoscopic examination and biopsies of sinus tissue.  Our studies of the sinus tissues include:  (1) performing laser capture microdissection of sinus tissue and processing of each tissue compartment for gene expression profiling by microarray, and (2) extracting and amplifying bacterial DNA from each sample for examination of the microbial community by gene sequencing.

 

Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis with Nasal Polyposis

Ellen J. Dutta, M.D., Principal Investigator

The goal of this study is to determine whether subcutaneous omalizumab (XolairR) is beneficial for treatment of chronic rhinosinusitis with nasal polyposis.  Subject enrolled in this study must have active polypoid chronic rhinosinusitis despite previous sinus surgery and one or more positive allergy skin tests to perennial allergens.  This is a double-blind, placebo-controlled clinical trial in which subjects will have a 50% chance of receiving omalizumab and 50% chance of receiving a placebo. 

This study involves allergy skin testing, nasal examination by rhinoscopy, sinus CT scanning and treatment with subcutaneous omalizumab or placebo. 

 

Carlos A. Camargo, M.D.

To learn about studies being conducted by Dr. Carlos A. Camargo, please use the following links:

Emergency Medicine Network (EMNet) www.emnet-usa.org

MGH Center for (vitamin) D-receptor Activation Research:  www.mghcedar.org

 

Hereditary Angioedema Study

Randomized Double-Blind Placebo Controlled Multicenter Study of Icatibant for Hereditary Angioedema

Aleena Banerji, MD., Principal Investigator

The goal of this study is to evaluate Icatibant for the treatment of acute hereditary angioedema attacks.  Subjects enrolled in this study must have a diagnosis of hereditary angioedema.  This is a double-blind, placebo-controlled clinical trial in which subjects will have a 50% chance of receiving Icatibant and 50% chance of receiving a placebo for their first attack.  All subsequent attacks will be treated with Icatibant. 

 

New Approaches to Diagnosing Carboplatin and Cisplatin Hypersensitivity

Aleena Banerji, MD., Principal Investigator

The goal of this study is to determine the sensitivity and specificity of the basophil activation test in relation to skin testing in women with a history of a hypersensitivity reaction to carboplatin or cisplatin. We will recruit women with recurrent ovarian cancer with (N=15) and without a history of a HSR (N=15) to platinum agents over a period of 6 months. These patients will  be evaluated with skin testing to carboplatin and cisplatin. A blood sample will be taken to evaluate basophil activity. We will then evaluate the sensitivity and specificity of the basophil activation test in comparison to skin testing.

 

Clinical Trial of Peanut Oral Immunotherapy

Wayne Shreffler, MD, PhD, Principal Investigator

This is an open label study on the efficacy of peanut oral immunotherapy that will recruit 32 peanut allergic individuals between 3 and 21 years of age.  Participants will be randomly assigned to either treatment (24) or observation (8) for the first approximately 12 months, after which time the observational control subjects may elect to receive treatment.  Treatment will consist of oral administration of increasing amounts of peanut flour over the course of 9-12 months, followed by peanut ingestion challenges to evaluate tolerance.

Enrollment is anticipated in Summer 2010.

 

Atopy Patch Testing for the Prediction of Relevant Food Allergens in Eosinophilic Esophagitis

Wayne Shreffler, MD, PhD, Principal Investigator

This is a prospective observational study of the usefulness of atopy patch testing for patients with food allergen caused eosinophilic esophagitis.  Participants will receive standard of care with the addition of patch testing.  Clinical and pathological outcomes will be related to the results of patch testing.  Patch test results will be compared to the gold-standard endoscopic biopsy findings of eosinophilia on systematic elimination diets.

Enrollment is anticipated in Fall 2010.

 

To learn more about any of these studies, please contact the Allergy Clinical Research Unit at 617-726-6376.

 

 

Aleena Banerji

Ten-year study of causes of moderate to severe angioedema seen by an inpatient allergy/immunology consult service.

Banerji A, Oren E, Hesterberg P, Hsu Y, Camargo CA Jr., Wong, JT.  Allergy Asthma Proc. 2008; 29: 88-92.

 

Multicenter study of patients with angiotensin-converting enzyme inhibitor-induced angioedema who present to the emergency department.

Banerji A, Clark S, Blanda M, LoVecchio F, Snyder B, Camargo, CA Jr.  Ann Allergy Asthma Immunol. 2008; 100: 327-332.

 

The spectrum of chronic angioedema.

Banerji A, Sheffer AL.  Allergy Asthma Proc. 2009; 30: 11-16.

 

Carlos Camargo

Regional variation in epinephrine autoinjector prescriptions in Australia: more evidence for the vitamin D-anaphylaxis hypothesis.

Mullins RJ, Clark S, Camargo CA Jr.  Ann Allergy Asthma Immunol 2009; 103: 488-495.

 

A randomized placebo-controlled study of intravenous montelukast for the treatment of acute asthma.

Camargo CA Jr, Gurner DM, Smithline HA, Chapela R, Fabbri LM, Green SA, Malice M-P, Legrand C, Dass SB, Knorr BA, Reiss TF.  J Allergy Clin Immunol 2010; 125: 374-380.

 

Multicenter study of repeat epinephrine treatments for food-related anaphylaxis.

Rudders SA, Banerji A, Corel B, Clark S, Camargo CA Jr.  Pediatrics 2010; 125: e711-718.

 

Daniel L. Hamilos

Chronic rhinosinusitis patients with polyps or polypoid mucosa have a greater burden of illness. 

Banerji A, Piccirillo JF, Thawley SE, Levitt RG, Schechtman KB, Kramper MA, Hamilos DL.   American Journal of Rhinology 2007; 21: 19-26.

 

Long-term safety study of levalbuterol administered via metered-dose inhaler in patients with asthma.

Hamilos DL, D'Urzo A, Levy RJ, Marcus M, Tripp K, Parsey M, Baumgartner RA, McVicar WK.  Ann Allergy Asthma Immunol. 2007; 99: 540-548.

 

Cigarette smoke combined with Toll-like receptor 3 signaling triggers exaggerated epithelial regulated upon activation, normal T cell expressed and secreted/CCL5 expression in chronic rhinosinusitis.

Yamin M, Holbrook EH, Gray ST, Harold R, Busaba N, Sridhar A, Powell KJ, Hamilos DL.  J Allergy Clin Immunol 2008; 122: 1145-1153.

 

Wayne Shreffler

Allergen-specific basophil activation associated with clinical tolerance in patients with milk allergy.

Wanich N, Nowak-Wegrzyn A, Sampson HA, Shreffler WG.  J All Clin Immunol 2009; 123: 789-794.

 

Association of allergen-specific regulatory T cells with the onset of clinical tolerance to milk protein.

Shreffler WG, Wanich N, Moloney M, Nowak-Wegrzyn A, Sampson HA.  J All Clin Immunol 2009; 123: 43-57.

 

 

Allergy Clinical Research Unit

Bulfinch 417
55 Fruit Street
Boston, MA 02114

Phone: 617-726-6376
Fax: 617-726-3847
Hours: Mon-Fri 8:30am-5pm

Public Transportation Access: yes
Disabled Access: yes

Clinical Research Coordinator:

Brooke Lovett

E-mail: blovett@partners.org