Severe IgE-mediated cow's milk allergy
Conditions
Brief summary
Proportion of subjects tolerating 300 mg cow's milk protein with no symptoms or only Grade 1 symptoms (oFASS-5) in the double-blind placebo-controlled oral cow's milk challenge trial (DBPCOC) without Omalizumab (without-Oz).
Detailed description
• Proportion of subjects tolerating the 300 mg dose of cow's milk protein with no or only Grade 1 symptoms (oFASS-5) in the double-blind placebo-controlled oral cow's milk challenge test (DBPCOC) at 4 months from initiation Omalizumab (Oz1). • Proportion of subjects tolerating >300 mg cow's milk protein with no or only Grade 1 symptoms (oFASS-5) in the open cow's milk oral challenge test (Oz1-a).
Interventions
Sponsors
Hospital Infantil Universitario Nino Jesus
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects tolerating 300 mg cow's milk protein with no symptoms or only Grade 1 symptoms (oFASS-5) in the double-blind placebo-controlled oral cow's milk challenge trial (DBPCOC) without Omalizumab (without-Oz). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of subjects tolerating the 300 mg dose of cow's milk protein with no or only Grade 1 symptoms (oFASS-5) in the double-blind placebo-controlled oral cow's milk challenge test (DBPCOC) at 4 months from initiation Omalizumab (Oz1). • Proportion of subjects tolerating >300 mg cow's milk protein with no or only Grade 1 symptoms (oFASS-5) in the open cow's milk oral challenge test (Oz1-a). | — |
Countries
Spain
Outcome results
None listed