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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02506998

Enrollment

Registered

2015-07-23

Start date

2013-08-31

Completion date

2015-01-31

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinoconjunctivitis

Keywords

Allergic rhinoconjunctivitis, Dialyzable Leukocyte Extracts

Brief summary

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

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.

Interventions

BIOLOGICALDLE

Adjuvant treatment

OTHERSecond generation anti histamines + Nasal corticosteroids

Standard treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026