# Controlling and preventing Asthma progression and Severity in Kids (CASK)

> **NIH NIH U01** · BOSTON CHILDREN'S HOSPITAL · 2020 · $171,250

## Abstract

Project Summary/Abstract
Asthma remains one of the most important challenges to pediatric public health in the US, affecting millions of
children, causing significant morbidity, mortality, and source of tremendous financial burden. Prevention of
asthma is a pressing, unmet need of utmost priority. The vast majority of children with persistent and chronic
asthma demonstrate aeroallergen sensitization (IgE antibody production), which remains the pivotal risk factor
for developing persistent, progressive asthma throughout life. It has recently been shown that aeroallergen
sensitization precedes viral wheezing and is the pivotal causal pathway and essential susceptibility factor in the
persistence and progression of the disease. Most aeroallergen sensitization begins around the age of 2-3
years and escalates during school age. The progression appears to be dependent on exposures to offending
allergens-- the greatest increase in development and impairment from asthma is seen in those with a tendency
toward Type 2 inflammation who are sensitized and exposed to high levels of offending allergens. In addition
to its role in mediating allergen-induced responses, IgE signals impair innate anti-viral immune responses
which could lead to increased viral infections and thus potentially further enhance the cascade of progression
to asthma. Omalizumab (anti-IgE) markedly reduces asthma exacerbations during the viral season and anti-
IgE treated children have demonstrated restored IFN-α response to rhinovirus. This suggests that anti-IgE
prevents IgE driven responses to offending allergen exposure in those with a Type 2 phenotype AND
attenuates viral infections in this Type 2 phenotype. Thus, utilizing anti-IgE in young children has the potential
to prevent the development of established asthma in susceptible children by blocking all IgE allergen-antibody
interactions (including responses to subclinical exposures) AND by reducing the response to viral exposure
which may lead to asthma. We hypothesize that blockade of IgE in young children (age 2-3) at high risk for
development of asthma will prevent progression to established asthma. We will test this hypothesis by
examining the effect of anti-IgE on the development of asthma in a double-blind, randomized, placebo-
controlled parallel trial of anti-IgE vs placebo in 250 children aged 2-3 years old at high risk of developing
asthma, who will be followed for 2 years after 2 years of therapy is discontinued. Primary outcome will be the
proportion of participants with current, active asthma as defined in the NIAID URECA birth cohort, between the
two treatment groups at the end of Year 4, the final 12 months of the trial off study medication. Secondary
outcomes will include occurrence of wheezing episodes, exacerbations requiring steroids, and new and
persistent allergen-specific IgE sensitizations after IgE therapy. If confirmed, anti-IgE therapy would be the first
intervention to change the natural history of child...

## Key facts

- **NIH application ID:** 10074697
- **Project number:** 3U01AI126614-05S1
- **Recipient organization:** BOSTON CHILDREN'S HOSPITAL
- **Principal Investigator:** WANDA PHIPATANAKUL
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $171,250
- **Award type:** 3
- **Project period:** 2016-07-20 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10074697

## Citation

> US National Institutes of Health, RePORTER application 10074697, Controlling and preventing Asthma progression and Severity in Kids (CASK) (3U01AI126614-05S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10074697. Licensed CC0.

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