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Completed

NCT Number: NCT02506998

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

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.

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Key information

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DLE

Biological

Adjuvant treatment

Other names: Transfer Factor, Transferon

Second generation anti histamines + Nasal corticosteroids

Other

Standard treatment

Primary outcomes

  1. Quality of Life

    Time frame: 11 weeks

    Quality of Life evaluated by Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(s)) Spanish version for Mexico

Sponsors and collaborators

Lead sponsor

National Polytechnic Institute, Mexico

Other

Collaborators

  • Instituto de Oftalmología Fundación Conde de Valenciana

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 23, 2015
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.