Children with allergies and wheezing have a high risk of developing lasting asthma and more allergies. The goal of the study is to see whether two years of treatment with Xolair® injections can prevent or lessen the severity of lasting asthma and reduce allergies.
Xolair® is a medication that’s approved to treat moderate to severe asthma among people 6 years of age and older. It works by blocking IgE which controls our body’s response to things such as food, pollen, and mold causing allergies and asthma.
We hope to learn if Xolair® helps prevent asthma as children grow older. We will also study if breathing problems are less severe among children treated with Xolair®, and if Xolair® will stop young kids from developing new allergies or reduce existing allergies.
As with any medication, there is a chance your child will experience an allergic reaction to Xolair®. The chance of an allergic reaction is very low. Xolair® will be administered to your child by healthcare providers prepared to manage severe reactions.
Xolair® will be given to half of the participating children and the other half will receive a placebo. The medication will be injected subcutaneously in either the thigh or upper arm. We will provide a numbing cream or ‘buzzy bee’ device to decrease any discomfort associated with the injection.
We’re looking for 2 and 3 year old children who have a history of wheezing as well as a parent or sibling who has asthma or allergies. These factors put children at a much higher risk of developing lasting and more severe asthma.
The study consists of a two year treatment period, followed by two years of observation. During the 2 year treatment period, we will ask you to come in once a month for study injection. Half of the children will receive Xolair, the other half treated with placebo. We will provide your child with an option of a numbing cream or “buzzy bee” device that should decrease any discomfort associated with the injection. We will then continue to see your child every 4 months for 2 years after the injections have stopped. This second phase is where we will look to see whether asthma is prevented or less severe than in the children who do not receive Xolair®.
There will be brief phone calls to check on your child’s health on months when you don’t come into the clinic. We will also test your child for allergies with a skin test. Blood will be obtained once a year to see how allergies are progressing.
Yes, participants families will receive compensation at each visit (up to a total of $2,540 over the four-year study), travel compensation, as well as free 24/7 access to study doctors for breathing symptom management (including free medications, if needed). Your child will also receive toys and other fun incentives.
