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Clinical Studies and Other Research

Clinical trials are an important way for medical researchers to expand existing knowledge, so that medical care can improve in the future. Whether or not to participate in clinical studies is an important individual decision that should be based on careful review of each study and discussion with your personal physician.

ASTHMA PREVENTION STUDIES AT BOSTON CHILDREN’S HOSPITAL

The Asthma/Allergy Clinical Research Center is an NIH funded Center currently recruiting for a number of studies for patients with asthma and/or allergies! All visits are compensated and all travel to and from the hospital is covered by the research group. The studies also provide free medications.

  • Preventing Asthma in High Risk Kids (PARK): is a prevention study aimed at identifying whether 2 years of treatment with Xolair® (AntiIgE) injections can prevent lasting asthma or reduce asthma severity in children ages 2-4 years with a history of wheezing, allergies, and family history. Xolair® (or Anti-IgE) has been safely established for decades to treat asthma in children and adults, but investigators want to study if early treatment could prevent or modify the disease. These children are at very high risk of developing lasting asthma and other allergic conditions. This treatment blocks IgE which is important in allergies and has been shown to provide antiviral benefits against the common cold. We will also evaluate whether this treatment stops or modifies the allergic march, which includes eczema, food allergies and other allergic conditions.
  • ORBEX (ORal Bacterial Extract for the prevention of wheezing lower respiratory tract illness): The goal of ORBEX is to find out if oral treatment with Broncho-Vaxom® for 2 years can prevent lower respiratory wheeze or asthma like symptoms in children ages 5-16 months who have eczema or who have a parent with asthma. The treatment is an oral treatment made of extracts of different kinds of bacteria responsible that has been established in Europe to treat children for common respiratory infections.
  • Vit-D Kids (Vitamin D to Prevent Severe Asthma Exacerbations): The goal of the Vit-D Kids study is to see if taking a large daily dose of Vitamin D for one year can reduce the number of severe asthma exacerbations experienced by asthmatic children ages 6-17 years old. All asthma controller medication is provided to the family during the course of the study.

The Asthma Clinical Research Center also has a number of observational studies, including EASY (Environmental
Assessment of Sleep in Youth) that is assessing the environment and providing home sleep monitoring, and evaluating the association between Activity Pediatric Outcomes in Children with Chronic Conditions, using a Fitbit in school aged children. We are also working on a variety of novel therapeutics to treat bad asthma. For more information about any of the above studies and/or for physicians to refer potential interested families, please email asthma@childrens.harvard.edu or call 857-218-5336.

-Wanda Phipatanakul, MD, MS, is the Director of the Asthma/Allergy Clinical Research Center, Boston Children’s Hospital, Professor of Pediatrics, Harvard Medical School

FOOD ALLERGY STUDIES AT MASS GENERAL HOSPITAL

“Outcome of Early Allergen Introduction,” (abbreviation LEAP-IT) sponsored by the Broad Institute. The primary goal of the study is to evaluate the success of introducing foods regarded as common allergens. The main eligibility criteria include: Age greater than or equal to 4 months and less than 4 years old, and a referral by a Massachusetts General Hospital allergist for food challenge as part of routine clinical care due to medical judgment of increased risk of allergy.

-Wayne Shreffler, MD, PhD, is division chief of Pediatric Allergy & Immunology at MassGeneral Hospital (MGH) for Children and director of the Food Allergy Center at MGH.

Additional information will be added to this page as it becomes available. Researchers: let us know about studies for which you are recruiting.