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Ojeda P.,Clinica de Asma y Alergia Dres | Pique N.,University of Barcelona | Alonso A.,Clinica Paracelso Medico Quirurgica | Delgado J.,University of Seville | And 7 more authors.
Allergy, Asthma and Clinical Immunology | Year: 2013

Background: Since barrier protection measures to avoid contact with allergens are being increasingly developed, we assessed the clinical efficacy and tolerability of a topical nasal microemulsion made of glycerol esters in patients with allergic rhinitis. Methods: Randomized, controlled, double-blind, parallel group, multicentre, multinational clinical trial in which adult patients with allergic rhinitis or rhinoconjunctivitis due to sensitization to birch, grass or olive tree pollens received treatment with topical microemulsion or placebo during the pollen seasons. Efficacy variables included scores in the mini-RQLQ questionnaire, number and severity of nasal, ocular and lung signs and symptoms, need for symptomatic medications and patients' satisfaction with treatment. Adverse events were also recorded. Results: Demographic characteristics were homogeneous between groups and mini-RQLQ scores did not differ significantly at baseline (visit 1). From symptoms recorded in the diary cards, the ME group showed statistically significant better scores for nasal congestion (0.72 vs. 1.01; p = 0.017) and mean total nasal symptoms (0.7 vs. 0.9; p = 0.045). At visit 2 (pollen season), lower values were observed in the mini-RQLQ in the ME group, although there were no statistically significant differences between groups in both full analysis set (FAS) and patients completing treatment (PPS) populations. The results obtained in the nasal symptoms domain of the mini-RQLQ at visit 2 showed the highest difference (-0.43; 95% CI: -0.88 to 0.02) for the ME group in the FAS population. The topical microemulsion was safe and well tolerated and no major discomforts were observed. Satisfaction rating with the treatment was similar between the groups. Conclusions: The topical application of the microemulsion is a feasible and safe therapy in the prevention of allergic symptoms, particularly nasal congestion. Trial registration: ClinicalTrials.gov Identifier: NCT01478425. © 2013 Ojeda et al.; licensee BioMed Central Ltd.


Ojeda P.,Clinica de Asma y Alergia Dres | Ojeda I.,Clinica de Asma y Alergia Dres | Pineda F.,Diater Laboratorios | Alfaya T.,Hospital Santa Barbara Of Puertollano | Ojeda J.A.,Clinica de Asma y Alergia Dres
Journal of Investigational Allergology and Clinical Immunology | Year: 2010

In Spain, peanut allergy is increasingly prevalent. Successful protocols for the induction of oral tolerance (IOT) with several foods have been reported. We aimed to induce clinical tolerance to peanut in a child with severe peanut allergy (age 4 years, facial urticaria and lip angioedema upon licking a peanut; peanut skin prick test, 13×10 mm; specific immunoglobulin (Ig) E > 100 kUA/L). At age 6, the threshold oral challenge dose was 62.5 mg. Several peanut solutions were prepared and sequentially administered at the patient's home. Over 138 days, the dose was increased from 0.625 to 5500 mg. There were 43 mild-to-moderate reactions (28% of the doses administered). Pre-IOT and post-IOT peanut IgE and IgG4 values were 265 vs 487 kUA/L, and 6.11 vs 14.8 mg/L. This is the first report of successful IOT to peanut in Spain. This home-based regimen is safe under permanent and close medical supervision by an allergist. © 2010 Esmon Publicidad.


Justicia J.L.,Stallergenes Iberica | Cardona V.,Hospital Universitari Vall dHebron | Guardia P.,Hospital Universitario Virgen Macarena | Ojeda P.,Clinica de Asma y Alergia Dres | And 5 more authors.
Journal of Allergy and Clinical Immunology | Year: 2013

Background: Satisfaction with treatment is a patient-reported outcome shown to be associated with the patient's health-related decisions and treatment-related behavior, thereby influencing the chances of successful treatment, and is especially relevant in long-term treatment, such as allergen-specific immunotherapy (AIT). Objective: We sought to assess the psychometric properties of the Satisfaction Scale for Patients Receiving Allergen Immunotherapy (ESPIA) questionnaire so as to determine the satisfaction of patients receiving AIT treatment. Methods: An observational, longitudinal, multicenter study was performed on patients with allergic rhinitis (AR) undergoing AIT treatment. Sociodemographic, clinical, and patient-centered health outcomes data were gathered at the study visits. Feasibility, reliability, validity, and sensitivity to change of the prevalidated version of the ESPIA questionnaire were assessed. Results: Four hundred twenty-nine patients were included (52.2% women, 33.6 years of age, 54.5% of the cases with intermittent AR and 62.5% with moderate AR). Low levels of missing items and ceiling/floor effects were found for the overall score of the ESPIA questionnaire. The overall Cronbach α value and intraclass correlation coefficient were 0.90 and 0.92, respectively. The overall score for the ESPIA questionnaire was strongly associated with months receiving AIT, AR type and intensity, presence of conjunctivitis, self-perceived health status, effect of AR on daily life, and expectations about the AIT treatment. The pattern of correlations obtained with other patient-centered health outcomes was consistent with expectations. The ESPIA questionnaire also showed good sensitivity to change for improved health status. Conclusion: The ESPIA questionnaire to assess patient satisfaction with respect to AIT treatment presented satisfactory psychometric properties for its use in clinical practice. © 2013 American Academy of Allergy, Asthma & Immunology.


Ojeda P.,Clinica de Asma y Alergia Dres | Ojeda I.,Clinica de Asma y Alergia Dres | Rubio G.,Clinica de Asma y Alergia Dres | Pineda F.,Diater Laboratories
Israel Medical Association Journal | Year: 2012

Background: In the last decade the use of different types of oral immunotherapy for food-allergic patients has increased with generally satisfactory outcomes. Cow's milk and hen's egg, a common element in the daily diet, have received the main interest. Most of these immunotherapy regimens are performed in the hospital, causing inconvenience for both children and their parents. Objectives: To assess the efficacy and safety of a home-based oral immunotherapy regimen with raw pasteurized egg. Methods: The study group comprised children aged 6 years and older with allergy to hen's egg proteins, proven by positive skin prick-tests (SPT) and/or specific immunoglobulin E (sIgE) and positive open oral food challenge (OOFC) with boiled or raw egg. Patients who met the inclusion criteria and signed the informed consent form underwent egg immunotherapy according to an established schedule. Results: The treatment was given to 31 of the 36 recruited patients: 80.6% of the intention-to-treat population achieved complete tolerance to the maximum dose equivalent to one raw hen's egg, 3.2% achieved incomplete tolerance, and 16.2% did not achieve an acceptable tolerance dose. Most of the latter patients had a positive baseline OOFC with low doses of boiled egg. The average number of reactions per treated patient was 5.8, most of them grades 1 and 2; there were no grade 4 reactions. Conclusions: This home-based oral immunotherapy protocol proved to effectively induce tolerance to hen's egg in most of the egg-allergic children and its safety profile was acceptable.


PubMed | Clinica de Asma y Alergia Dres
Type: Journal Article | Journal: Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology | Year: 2013

Since barrier protection measures to avoid contact with allergens are being increasingly developed, we assessed the clinical efficacy and tolerability of a topical nasal microemulsion made of glycerol esters in patients with allergic rhinitis.Randomized, controlled, double-blind, parallel group, multicentre, multinational clinical trial in which adult patients with allergic rhinitis or rhinoconjunctivitis due to sensitization to birch, grass or olive tree pollens received treatment with topical microemulsion or placebo during the pollen seasons. Efficacy variables included scores in the mini-RQLQ questionnaire, number and severity of nasal, ocular and lung signs and symptoms, need for symptomatic medications and patients satisfaction with treatment. Adverse events were also recorded.Demographic characteristics were homogeneous between groups and mini-RQLQ scores did not differ significantly at baseline (visit 1). From symptoms recorded in the diary cards, the ME group showed statistically significant better scores for nasal congestion (0.72 vs. 1.01; p=0.017) and mean total nasal symptoms (0.7 vs. 0.9; p=0.045). At visit 2 (pollen season), lower values were observed in the mini-RQLQ in the ME group, although there were no statistically significant differences between groups in both full analysis set (FAS) and patients completing treatment (PPS) populations. The results obtained in the nasal symptoms domain of the mini-RQLQ at visit 2 showed the highest difference (-0.43; 95% CI: -0.88 to 0.02) for the ME group in the FAS population. The topical microemulsion was safe and well tolerated and no major discomforts were observed. Satisfaction rating with the treatment was similar between the groups.The topical application of the microemulsion is a feasible and safe therapy in the prevention of allergic symptoms, particularly nasal congestion.ClinicalTrials.gov Identifier: NCT01478425.


PubMed | Clinica de Asma y Alergia Dres
Type: Journal Article | Journal: The Israel Medical Association journal : IMAJ | Year: 2012

In the last decade the use of different types of oral immunotherapy for food-allergic patients has increased with generally satisfactory outcomes. Cows milk and hens egg, a common element in the daily diet, have received the main interest. Most of these immunotherapy regimens are performed in the hospital, causing inconvenience for both children and their parents.To assess the efficacy and safety of a home-based oral immunotherapy regimen with raw pasteurized egg.The study group comprised children aged 6 years and older with allergy to hens egg proteins, proven by positive skin prick-tests (SPT) and/orspecific immunoglobulin E (sIgE) and positive open oral food challenge (OOFC) with boiled or raw egg. Patients who met the inclusion criteria and signed the informed consent form underwent egg immunotherapy according to an established schedule.The treatment was given to 31 of the 36 recruited patients: 80.6% of the intention-to-treat population achieved complete tolerance to the maximum dose equivalent to one raw hens egg, 3.2% achieved incomplete tolerance, and 16.2% did not achieve an acceptable tolerance dose. Most of the latter patients had a positive baseline OOFC with low doses of boiled egg. The average number of reactions per treated patient was 5.8, most of them grades 1 and 2; there were no grade 4 reactions.This home-based oral immunotherapy protocol proved to effectively induce tolerance to hens egg in most of the egg-allergic children and its safety profile was acceptable.

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