Investigate the role of the drug in the possible allergic reactions as a cofactor
Conditions
Interventions
Trade Name: Aspirina - Tablet - Acetylsalicylic acid 500 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
CAS Number: 50-78-2
Salicylic acid acetate
o-Acetoxybenzoic acid
o-Carboxyphenyl acetate
A.S.A.
A.S.A. Empirin
Acenterine
Acesal
Acetal
Aceticyl
Acetilum Acidulatum
Acetisal
Acetol
Acetophen
Acetosal
Acetosalic acid
Acetosalin
Acetylin
Acetylsal
Acetylsalicylic acid
Sponsors
HOSPITAL UNIVERSITARIO FUNDACION ALCORCON
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients seen in our Allergy Unit since 2008 to 2014, that meet all the inclusion criteria: • Patients desensitized to milk and / or egg = 12 years, who have 3 years in maintenance phase who have not had reactions in the last year in relation to the food intake (milk or egg) or derivatives; that have been informed and that they sign the corresponding informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: 32 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients desensitized to milk and / or egg that do not meet the inclusion criteria • Patients with a history of severe or moderate uncontrolled asthma • Patients who have presented a reaction in relation to the foods or derivatives in the last year • Patients who are taking premedication in the maintenance phase • Patients diagnosed with hypersensitivity to NSAIDs • Patients diagnosed with asthma induced by exercise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Analyze if the exercise or treatment with NSAIDs increases the risk of reaction in children desensitized to milk and eggs with three or more years in maintenance phase that have not presented reactions after food in the last year.; Secondary Objective: - Evaluate if there is a relationship between the severity of symptoms at diagnosis or at the beginning of desensitization with non-tolerance of cofactors. - Evaluate if there are differences between the IgE specific values ??and prick test to cow and egg milk proteins, at the beginning of desensitization and at the beginning of the study, between children who tolerate cofactors and those who do not tolerate them. - Evaluate the quality of life before and after knowing the tolerance or not to the taking of NSAIDs and the performance of exercise immediately after the ingestion of milk and / or egg ;Primary end point(s): The tolerance or not to exercise or the taking of NSAIDs after taking the food to which the child is desensitized.;Timepoint(s) of evaluation of this end point: In the moment of the drug provocation test | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary variables that will be measured will be the size of the skin test and the values ??of the specific IgE at the beginning of the desensitization and at the beginning of the study. IgG4 values ??will also be assessed at the beginning of the study. It will be evaluated if these variables depend on the tolerance or not of the cofactors. The impact on the quality of life that gives the tolerance of the cofactors at the beginning, at 3, 6 and 9 months after the provocation will also be valued. ; Timepoint(s) of evaluation of this end point: Skin tests and IgE and IgG4 values ??will be assessed at the beginning of desensitization and subsequently before the study. The impact of quality of life will be assessed before starting the study, at 3, 6 and 9 months. | — |
Countries
Spain
Contacts
Public ContactHOSPITAL UNIVERSITARIO FUNDACION AL
HOSPITAL UNIVERSITARIO FUNDACION ALCORCON
Outcome results
None listed