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

NCT ID: NCT02506998

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-01-31

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.

Conditions

Allergic Rhinoconjunctivitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DLE plus standard medications

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

Group Type: EXPERIMENTAL

DLE

Intervention Type: BIOLOGICAL

Adjuvant treatment

Second generation anti histamines + Nasal corticosteroids

Intervention Type: OTHER

Standard treatment

Interventions

DLE

Adjuvant treatment

Intervention Type: BIOLOGICAL

Second generation anti histamines + Nasal corticosteroids

Standard treatment

Intervention Type: OTHER

Other Intervention Names

Transfer Factor; Transferon

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Oftalmología Fundación Conde de Valenciana

OTHER

Sponsor Role: collaborator

National Polytechnic Institute, Mexico

OTHER

Sponsor Role: lead

Responsible Party

Maria C Jimenez Martinez

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Toni Homberg, MD

Role: PRINCIPAL_INVESTIGATOR

National Polytechnic Institute

References

Homberg TA, Lara I, Andaluz C, Cervantes-Trujano E, Hernandez-Martinez PM, Perez-Tapia SM, Jimenez-Martinez MC. Quality of life in adult patients using dialyzable leukocyte extract for allergic rhinitis. Medicine (Baltimore). 2023 Jul 7;102(27):e34186. doi: 10.1097/MD.0000000000034186.

Reference Type: DERIVED

PMID: 37417619 (View on PubMed)

Other Identifiers

IC-13-001

Identifier Type: -

Identifier Source: org_study_id