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

Primary Purpose

Allergic Rhinoconjunctivitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
DLE
Second generation anti histamines + Nasal corticosteroids
Sponsored by
National Polytechnic Institute, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinoconjunctivitis focused on measuring Allergic rhinoconjunctivitis, Dialyzable Leukocyte Extracts

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    DLE plus standard medications

    Arm 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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 21, 2015
    Last Updated
    July 24, 2015
    Sponsor
    National Polytechnic Institute, Mexico
    Collaborators
    Instituto de Oftalmología Fundación Conde de Valenciana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02506998
    Brief Title
    Quality of Life in Allergic Rhinoconjunctivitis Patients Treated With Dialyzable Leukocyte Extracts
    Official Title
    Evaluation of Quality of Life in Allergic Rhinoconjunctivitis Patients Treated With Dialyzable Leukocyte Extracts as an Adjuvant
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Polytechnic Institute, Mexico
    Collaborators
    Instituto de Oftalmología Fundación Conde de Valenciana

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Rhinoconjunctivitis
    Keywords
    Allergic rhinoconjunctivitis, Dialyzable Leukocyte Extracts

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DLE plus standard medications
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Biological
    Intervention Name(s)
    DLE
    Other Intervention Name(s)
    Transfer Factor, Transferon
    Intervention Description
    Adjuvant treatment
    Intervention Type
    Other
    Intervention Name(s)
    Second generation anti histamines + Nasal corticosteroids
    Intervention Description
    Standard treatment
    Primary Outcome Measure Information:
    Title
    Quality of Life
    Description
    Quality of Life evaluated by Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(s)) Spanish version for Mexico
    Time Frame
    11 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Toni Homberg, MD
    Organizational Affiliation
    National Polytechnic Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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