Physicians Information

What are the objectives?

The GPAC Study is a Phase II multi-centre, double-blind, random, placebo-controlled trial using immunoprophylaxis in the primary prevention of allergic disease.

• The primary objective of this trial is to assess whether oral mucosal immunoprophylaxis (OMIP) reduces allergic sensitization in children at high genetic risk of asthma and atopy

• The secondary objective of this trial is to assess whether OMIP reduces the incidence of asthma in children at high genetic risk of asthma and atopy

• The tertiary objective of this trial is to determinate the mechanism by which OMIP induces immunological tolerance to the allergens in treatment mix

• The children will be randomly assigned to receive daily sublingual drops of either allergen mix (house dust mite, timothy grass and cat) or placebo for 12 months. The development of allergic sensitization and asthma in these children will be assessed 3 years after the end of study treatment (i.e. 4 years after the initiation of therapy).

To be eligible children must be between 18 and 30 months of age, with a weight of at least 9.5 Kg. They must have atopic dermatitis, a food allergy and a well-documented family history of atopy (defined as atopic dermatitis, allergic rhinitis and asthma). They must not have a previous diagnosis of asthma.     About OMIP The choice of the oral mucosal route is based on the goal of achieving high-dose antigen exposure in local mucosal    draining    lymph    nodes,

including those that drain the tongue and nasolabial lymphoid plexus. Oral mucosal immunoprophylaxis (OMIP) is a closely related route of administration to Sublingual immunotherapy (SLIT) which has been demonstrated to be safe in sensitized patients as young as 2 years of age.

The possible adverse events of OMIP are related to allergic responses to the allergens in treatment mix. In recent reviews it is reported that the most frequent side effect with SLIT was oral or sublingual itching followed by non-specific gastrointestinal complaints (as nausea, vomiting, abdominal pain). No severe systemic reactions have been reported in the literature with more than 15 years of use in children.


Referrals

If you would like additional information on the GPAC Study, or if you are caring for a patient who you believe may be eligible for the study, please contact the study coordinator at your closest clinical centre.
 

More details are listed in Study Locations page.