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
About this trial
This is an interventional treatment trial for Allergic Rhinoconjunctivitis focused on measuring Allergic rhinoconjunctivitis, Dialyzable Leukocyte Extracts
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.
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
NCT ID
NCT02506998
First Posted
July 21, 2015
Last Updated
July 24, 2015
Sponsor
National Polytechnic Institute, Mexico
Collaborators
Instituto de Oftalmología Fundación Conde de Valenciana
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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