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

Allergic Rhinoconjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506998
• Other study ID #: IC-13-001
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2015
• Last updated: July 24, 2015
• Start date: August 2013
• Est. completion date: January 2015

Study information

• Verified date: July 2015
• Source: National Polytechnic Institute, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Biological:
• DLE
Adjuvant treatment

Other:
• Second generation anti histamines + Nasal corticosteroids
Standard treatment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Polytechnic Institute, Mexico	Instituto de Oftalmología Fundación Conde de Valenciana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	Quality of Life evaluated by Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(s)) Spanish version for Mexico	11 weeks	No