Omalizumab in Severe Asthmatics With Food Allergy (NCT06316414) | Clinical Trial Compass
CompletedNot Applicable
Omalizumab in Severe Asthmatics With Food Allergy
Italy65 participantsStarted 2018-01-01
Plain-language summary
A prospective assessment of the impact of Omalizumab in terms of efficacy, safety, and quality of life (FA-QoL) in patients with moderate/severe asthma and history of anaphylaxis to peanut, tree nuts, fish, egg, milk, and/or wheat. Evaluation of the trend of total and specific IgE during Omalizumab treatment.
Who can participate
Age range6 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 6 - 18 years
* Severe persistent allergic asthma according to the GINA guidelines
* Sensitized to a perennial aeroallergen, as witnessed by positive skin test and/or in vitro reactivity
* Symptoms inadequately controlled with inhaled corticosteroids + another medication, as witnessed by an ACT ≤ 19
* On treatment with high dose inhaled corticosteroids + another medication. Threshold dose for inhaled corticosteroids set at 400 mcg/day budesonide (or equivalent doses) for children \< 12 years, at 800 mcg/day for older patients.
* Immediate food allergy with anaphylactic symptoms within 1hr. of ingestion of milk, egg, wheat, peanut, hazelnut, and/or codfish.
* Total IgE \< 70 and \>1,500 kU/L at baseline
* Sensitivity to food allergen documented by a positive skin prick test result and/or allergen-specific IgE level, with 0.35 kU/L as a lower limit of eligibility
* Positive OFC within the past 12 months, with minimal or no reactions to the placebo challenge.
* Trained on the proper use of epinephrine
* In case of female subjects of child-bearing potential, negative human chorionic gonadotropin blood sample for pregnancy testing
* No known contraindications to oral immunotherapy with food protein or Omalizumab
* Parent/legal guardian written informed consent
Exclusion Criteria:
* Total IgE at screening \> 70 or ≤ 2,500 kUI/L
* allergy to food(s) not investigated in this study
* Immune deficiency
* Previous reaction to Omalizumab
* Previous organ trans…
What they're measuring
1
Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1.
Timeframe: Four months (T1)
Trial details
NCT IDNCT06316414
SponsorBambino Gesù Hospital and Research Institute