Allergic RhinoconjunctivitisPhase 2NCT02506998
Quality of Life in Allergic Rhinoconjunctivitis Patients Treated With Dialyzable Leukocyte Extracts
A Phase 2 study testing DLE and Second generation anti histamines + Nasal corticosteroids in people with Allergic Rhinoconjunctivitis, run by National Polytechnic Institute, Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- DLE and Second generation anti histamines + Nasal corticosteroids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Jan 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Evaluation of Quality of Life in Allergic Rhinoconjunctivitis Patients Treated With Dialyzable Leukocyte Extracts as an Adjuvant
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.
Read the 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
- Being tested
- DLE, Second generation anti histamines + Nasal corticosteroids
- Keywords
- Allergic rhinoconjunctivitis, Dialyzable Leukocyte Extracts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLEBiological
Also called Transfer Factor, Transferon
Adjuvant treatment
Second generation anti histamines + Nasal corticosteroidsOther
Standard treatment
| Study group | Role | What they receive |
|---|---|---|
| DLE plus standard medications | Experimental | 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 Receives: Biological: DLE; Other: Second generation anti histamines + Nasal corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Quality of Life evaluated by Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(s)) Spanish version for Mexico
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startAug 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Polytechnic Institute, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Oftalmología Fundación Conde de Valenciana
- Responsible party
- Principal investigator, Maria C Jimenez Martinez, National Polytechnic Institute, Mexico
- Investigators
- Toni Homberg, MD, Principal investigator, National Polytechnic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506998
- Sponsor's protocol ID
- IC-13-001
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2015
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37417619
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality of Life in Allergic Rhinoconjunctivitis Patients Treated With Dialyzable Leukocyte Extracts as an Adjuvant
- ClinicalTrials.gov ID
- NCT02506998
- Acronym / sponsor ID
- IC-13-001
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Allergic rhinoconjunctivitis, Dialyzable Leukocyte Extracts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Polytechnic Institute, MexicoUniversity, hospital or other
- Collaborators
- Instituto de Oftalmología Fundación Conde de Valenciana
- Study start
- Aug 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DLE plus standard medications | Experimental | Biological: DLE, Other: Second generation anti histamines + Nasal corticosteroidsDLE + 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 |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DLEAlso: Transfer Factor, TransferonAdjuvant treatment | Biological | DLE plus standard medications |
| Second generation anti histamines + Nasal corticosteroidsStandard treatment | Other | DLE plus standard medications |
Primary outcome
Quality of Life
Time frame: 11 weeks
Quality of Life evaluated by Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(s)) Spanish version for Mexico
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- Derived from this study: PubMed 37417619Homberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toni Homberg, MD principal investigator
National Polytechnic Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DLE and Second generation anti histamines + Nasal corticosteroids in people with Allergic Rhinoconjunctivitis, run by National Polytechnic Institute, Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.