Currently viewing the tag: "clinical study"

Dr Ruchi GuptaFindings presented Monday at the American College of Allergy, Asthma & Immunology (ACAAI) 2015 Annual Scientific Meeting suggest that testing the siblings of children diagnosed with food allergies is not advisable. These tests often return positive results even though the child does not have allergy. False positives generally lead to food avoidance which may increase the risk for developing an allergy later in life.

“Many children are sensitized to a food, so they will have a positive test result, but that does not mean they have a true food allergy,” said Ruchi Gupta, MD, lead researcher on the study from the Northwestern University Feinberg School of Medicine in Chicago.

The study involved 478 children with confirmed food allergy and 642 of their siblings. Each sibling was given skin prick tests and serologic immunoglobulin E (sigE) for cows milk, egg white, soybean, wheat, peanut, walnut, sesame seed, a fish mix and a shellfish mix. The siblings were then observed for 2 hours after ingesting the foods for clinical signs of allergy, including hives, breathing difficulties or shortness of breath, repetitive coughing, wheezing or chest tightness, throat tightness, choking or difficulty swallowing, tongue swelling, fainting, dizziness, light-headedness or decreased consciousness, and vomiting.

Food allergy was defined as a positive skin prick test plus symptoms, while sensitization was defined as a positive skin prick test or positive sigE and an absence of symptoms.

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pharma-moneyTwo emerging therapies received the Food and Drug Administration’s (FDA) “Breakthrough” designation for the treatment of food allergy this year. We’ll take a look at what it means to be a breakthrough therapy, who is developing these them, how they work, and the (big) business drivers behind them.

The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in July 9, 2012. Section 902 of the legislation provides for a new fast track designation – Breakthrough Therapy. According to the FDA, a breakthrough therapy is a drug:

  • intended for use alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
  • preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

A drug given such a designation is provided expedited review by the FDA, though the sponsor must still demonstrate that it is effective and safe. The FDA assigns senior resources to work with the sponsor on a continual basis to speed up the entire process from clinical trials through approval.

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cincinattiChildrensResearchers at the Cincinnati Children’s Hospital Medical Center may have solved a crucial piece of the puzzle in determining why some people with food allergies have relatively mild reactions while others suffer full-blown anaphylaxis.

The team fed egg white to mice specially bred to react to the protein. They found that the mice with large quantities of mucosal mast cells (MMC9) in their intestines produced large quantities of interleukin 9 (IL-9) – known to amplify reactions. The mice with MMC9 cells  subsequently reacted with severe anaphylaxis-like symptoms while those without them did not. The source of IL-9 was previously unknown.

The researchers then eliminated the MMC9 cells in the mice with an antibody and the anaphylactic symptoms ceased. When the mast cells were restored, the reactions returned.

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patchDBV Technologies, the firm that received the Food and Drug Administration’s (FDA) Breakthrough Therapy Designation for their peanut patch in April, issued a press release stating that the board overseeing their milk patch Phase I trial found no safety concerns and is recommending the therapy progress on to Phase II.

Phase I studies focus on the safety of a new therapy while Phase II studies focus on a therapy’s efficacy. Pending a review of the Phase I data by the FDA and approval of the proposed Phase II protocol, the firm expects to continue on to the Phase II study in the second half of 2015.

DBV describes Viaskin® as “an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.” In other words, the patch therapy introduces increasing quantities of an allergen through the skin and by doing so desensitizes the individual to that allergen.

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Dr Ruchi GuptaIn a study of discharge data collected over 5 years from over 200 hospitals in Illinois, it was determined that emergency room visits and hospitalizations of children with severe food allergies rose an average of 30% each year between 2008 and 2012.

The study, led by Dr. Ruchi Gupta, professor of pediatrics at Northwestern University Feinberg School of Medicine and attending physician at Ann & Robert H. Lurie Children’s Hospital of Chicago, focused on children that suffered anaphylaxis, a potentially fatal allergic reaction.

Previously, white children and those from higher-income families were affected most by food allergies, but the study shows that the rates of Hispanic, African American and lower-income children are skyrocketing as well.

“This study shows that severe food allergies are beginning to impact children of all races and income. This is no longer primarily a disease of children who are white and/or from middle-to-high income families. Nobody is immune to it,” said Dr Gupta.

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American-Thoracic-SocietyIn a study to be presented at the ongoing American Thoracic Conference (ATS) 2015, it was determined that many children suffering from asthma have a sensitivity to peanuts but their families are unaware.

“Many of the respiratory symptoms of peanut allergy can mirror those of an asthma attack, and vice versa. Examples of those symptoms include shortness of breath, wheezing and coughing,” said study lead author Robert Cohn, MD, MBA. “This study aimed to evaluate the proportion of asthmatic children who also demonstrated a sensitivity to peanuts.”

The study researched the charts of 1517 children diagnosed with asthma at Mercy Children’s Hospital in Toledo, Ohio. Of the charts reviewed, 665 (43.8%) had IgE testing for peanuts, and of this group 148 (22.3%) had positive results.

Of the children with positive IgE tests, more than half (53%) of the children and their families did not suspect there was any sensitivity to peanut.

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02-peanutsA study of the accidental exposure of children with physician-confirmed peanut allergy was published in the Journal of Clinical and Translational Allergy earlier this month.

The parents of 1941 children were recruited from Canadian allergy clinics and allergy advocacy organizations over a ten year period beginning in 2004, who completed questionnaires regarding the accidental exposure to peanuts of their children over the preceding year and the results were correlated.

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patchIn positive news, DBV Technologies, a French firm developing skin patch therapies for various allergens, issued a press release announcing their Viaskin® Peanut patch has received “Breakthrough Therapy” (BT) designation from the US Food and Drug Administration (FDA).

DBV describes Viaskin as “an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.”

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bag-of-plateletsAccording to a study published today in the Canadian Medical Association Journal, allergies to specific foods can be passed via blood transfusions, though such cases are extremely rare.

The research was initiated after an eight year old Canadian boy with no history of food allergies suddenly experienced an anaphylactic reaction to salmon after receiving a transfusion of platelets as part of ongoing chemotherapy treatment. Four days later he had a reaction to peanuts.

Investigators traced the source of the platelets and found that a single donor had multiple severe food allergies including fish and peanuts.

Though extremely rare, researchers found that food allergies can be passed through an antibody that reacts against allergens, immunoglobulin E (IgE). IgE is found in blood platelets.

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Food challenge: where the patient consumes a food they may be allergic to while the medical staff hovers nearby, ready to inject epinephrine if the symptoms of a severe allergic reaction appear. Low-tech, dangerous, and the only reliable way to test how severely someone may react to an allergen. Until now.

A blood test resulting from a study led by researchers from The Mindich Child Health and Development Institute and the Jaffe Food Allergy Institute promises to predict which people will have severe allergic reactions to specific foods. The study was published yesterday in The Annals of Allergy, Asthma & Immunology accompanied by a press release by Mount Sinai.

Current testing relies on skin pricks and blood tests that detect proteins called allergen-specific IgE produced by the immune system, though these cannot accurately predict the severity of reactions. The study reports that measuring another immune system component, the basophil, can accurately predict how a person will react to specific allergens. The basophil activation test (BAT) requires only a small amount of blood and provides quick results.

“While providing crucial information about their potential for a severe allergic reaction to a food, having blood drawn for BAT testing is a much more comfortable procedure than food challenges.” says first author Ying Song, MD. “Although food challenges are widely practiced, they carry the risk of severe allergic reactions, and we believe BAT testing will provide accurate information in a safer manner.”

Note that BAT testing is currently only approved for research study.

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