Quality of Life in Allergic Rhinoconjunctivitis Patients Treated With Dialyzable Leukocyte Extracts

Study Overview
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Brief Summary
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The purpose of this study is to determine the changes of quality of life of patients with allergic rhinoconjunctivitis treated with standard medications plus Dialyzable Leukocyte Extracts (DLE). All patients will receive DLE in combination with current guide lines-suggested standard medication.

Detailed Description
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DLE are heterogenous mixtures of peptides under 10 kilo Daltons (kDa) obtained after disruption of peripheral blood leukocytes from healthy human donors. DLE have been reported to improve clinical response in allergies, such as asthma and atopic dermatitis. The therapeutic effect of DLE is related to an immune modulatory effect that changes innate signaling pathways, such as Toll Like Receptors, and Nuclear Factor -kappa B; production of cytokines might also be modified with the use of DLE, including Tumor Necrosis Factor a, Interleukin (IL)-6, and induction of Interferon-g secretion, driving immune response to a T-helper Th1 immune-regulatory response, and thus helping to reduce allergy symptoms.

Official Title
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Evaluation of Quality of Life in Allergic Rhinoconjunctivitis Patients Treated With Dialyzable Leukocyte Extracts as an Adjuvant

Conditions
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Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Biological: DLE
* Other: Second generation anti histamines + Nasal corticosteroids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of symptomatic seasonal or perennial allergic rhinitis Active rhinoconjunctivitis Six week standard treatment before inclusion Confirmation of an Immunoglobulin E-mediated response through previous positive skin or in vitro allergen testing Exclusion Criteria: Other immunological immune-mediated diseases such as autoimmune diseases and cancer. Unstable chronic disease, such as diabetes, cardiac diseases, chronic kidney failure, chronic hepatic disease.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DLE plus standard medications<br>DLE + Second generation anti histamines + Nasal corticosteroids DLE 2mg/5 milliliters (mL) P.O. every 24h per 5 days, followed by 2 mg/mL P.O. twice weekly for 5 weeks, follow by 2 mg/5mL per week for 5 weeks. Second generation anti histamines at standard dosis every 24h, and Nasal corticosteroids two spray released per nostril every 24 h per 11 weeks | Biological: DLE<br>* Adjuvant treatment<br>* Other names: Transferon;Other: Second generation anti histamines + Nasal corticosteroids<br>* Standard treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of Life evaluated by Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(s)) Spanish version for Mexico | 11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic rhinoconjunctivitis, Dialyzable Leukocyte Extracts