EUCTR2017-005038-53-ES
Active, not recruiting
Phase 1
Randomized double-blind, placebo-controlled study evaluate the efficacy and mechanisms involved in immunotherapy Sublingual specifies with Pru p 3 (Pru p 3-ITSL) in patients with allergy to nsLTP with severe symptoms in its response to Peach, peanut, artemisia and olive.
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud (FIMABIS)0 sites99 target enrollmentNovember 23, 2018
ConditionsTP syndrome.MedDRA version: 20.0 Level: PT Classification code 10016946 Term: Food allergy System Organ Class: 10021428 - Immune system disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
DrugsSLIT-Melocotón
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- TP syndrome.
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud (FIMABIS)
- Enrollment
- 99
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Informed Consent (IC) for the study and for the Biobank signed
- •2\. Men or women \=5 and \=55 years of age.
- •3\. Moderate/severe allergic reaction after ingestion of peach, with or without peanut, confirmed by PPDCCP with peach.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 33
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 66
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Pregnancy and lactation.
- •2\. Immunological diseases, treatments with immunomodulators and/or blockers.
- •3\. Mental illness.
- •4\. Severe atopic dermatitis according to SCORAD (53\)
- •5\. FEV1 \<70%.
- •6\. Inflammation in the oral cavity with severe symptoms, oral surgery in the previous 7 days.
Outcomes
Primary Outcomes
Not specified
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