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

National Polytechnic Institute, Mexico

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinoconjunctivitis

Treatments: Biological: DLE; Other: Second generation anti histamines + Nasal corticosteroids

Study type: Interventional

Funder types: Other

Identifiers

NCT02506998

IC-13-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 14 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

DLE plus standard medications

Experimental group

Description:

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

Treatment:

Other: Second generation anti histamines + Nasal corticosteroids

Biological: DLE