Quality of Life in Allergic Rhinoconjunctivitis Patients Treated With Dialyzable Leukocyte Extracts
Evaluation of Quality of Life in Allergic Rhinoconjunctivitis Patients Treated With Dialyzable Leukocyte Extracts as an Adjuvant
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2013
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 21, 2015
CompletedFirst Posted
Study publicly available on registry
July 23, 2015
CompletedJuly 28, 2015
July 1, 2015
1.4 years
July 21, 2015
July 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life
Quality of Life evaluated by Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(s)) Spanish version for Mexico
11 weeks
Study Arms (1)
DLE plus standard medications
EXPERIMENTALDLE + 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
Interventions
Adjuvant treatment
Standard treatment
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of symptomatic seasonal or perennial allergic rhinitis
- Active rhinoconjunctivitis
- Confirmation of an Immunoglobulin E-mediated response through previous positive skin or in vitro allergen testing
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 37417619DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Toni Homberg, MD
National Polytechnic Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
July 21, 2015
First Posted
July 23, 2015
Study Start
August 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
July 28, 2015
Record last verified: 2015-07