Back to resultsA Multicenter, Open Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica
Primary Purpose
Rhinoconjunctivitis
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Allergovac depot with Parietaria judaica pollen extract
Sponsored by
About this trial
This is an interventional treatment trial for Rhinoconjunctivitis focused on measuring allergy, SCIT
Eligibility Criteria
Inclusion Criteria:
- Patients must sign the informed consent form.
- Patients must be between 18 and 60 years of age.
- Patients with seasonal allergic rhinoconjunctivitis against Parietaria judaica during a minimum of 2 years prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2013).
- Patients who obtained a prick test result ≥ 3 mm diameter to Parietaria judacia. Positive and negative control of the test should give consistent results.
- Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to Parietaria judaica.
- Patients sensitized to Parietaria judaica with clinically relevant symptoms in which treatment with Parietaria judaica 100% vaccine is indicated.
- Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0.
- Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active.
Exclusion Criteria:
- Patients who received immunotherapy in the previous 5 years for Parietaria judaica or fo rany allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
- Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1< 70% even if the are pharmacologically controlled .
- Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.
- Patients with a previous history of anaphylaxis
- Patients with chronic urticaria,
- Patients with moderate to severe atopic dermatitis
- Patients who have participated in another clinical trial within 3 month prior to enrolment.
- Patients under treatment with tricyclic antidepressives, phenothiazines , β-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
- Female patients who are pregnant or breast-feeding
- Patient who does not attend the visits
- Patient's lack of collaboration or refusal to participate.
Sites / Locations
- Hospital Vega Baja
- Hospital de Manises
- Hosptal de Sagunto
- Hospital Universitario y Politécnico La Fe
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allergovac depot
Arm Description
Allergovac depot with Parietaria judaica pollen extract
Outcomes
Primary Outcome Measures
Number and severity of adverse reactions as a measure of Safety and tolerability
Secondary Outcome Measures
Immunoglobulin changes from baseline
Skin reactivity changes from baseline
Full Information
NCT ID
NCT02477917
First Posted
June 1, 2015
Last Updated
April 28, 2017
Sponsor
Roxall Medicina España S.A
1. Study Identification
Unique Protocol Identification Number
NCT02477917
Brief Title
A Multicenter, Open Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica
Official Title
A Multicenter, Open Clinical Trial With Subcutaneous Immunotherapy in Depot in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roxall Medicina España S.A
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with Parietaria judaica pollen extract in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
Detailed Description
Parietaria judaica is a weed widespread throughout the Mediterranean área. Prevalence of sensitization to Parietaria judaica's pollen is very high in the Mediterranean areas, reaching 41.4% among allergic patients on the Spanish Mediterranean coast.
The study has been designed as an open trial which will be conducted in 4 Spanish sites.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoconjunctivitis
Keywords
allergy, SCIT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allergovac depot
Arm Type
Experimental
Arm Description
Allergovac depot with Parietaria judaica pollen extract
Intervention Type
Biological
Intervention Name(s)
Allergovac depot with Parietaria judaica pollen extract
Intervention Description
Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly dose increasing injections at the initiation phase plus 3 maintenance monthly injections
Primary Outcome Measure Information:
Title
Number and severity of adverse reactions as a measure of Safety and tolerability
Time Frame
across 17 weeks treatment period
Secondary Outcome Measure Information:
Title
Immunoglobulin changes from baseline
Time Frame
At baseline and 1 week after last administered dose
Title
Skin reactivity changes from baseline
Time Frame
At baseline and 1 week after last administered dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must sign the informed consent form.
Patients must be between 18 and 60 years of age.
Patients with seasonal allergic rhinoconjunctivitis against Parietaria judaica during a minimum of 2 years prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2013).
Patients who obtained a prick test result ≥ 3 mm diameter to Parietaria judacia. Positive and negative control of the test should give consistent results.
Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to Parietaria judaica.
Patients sensitized to Parietaria judaica with clinically relevant symptoms in which treatment with Parietaria judaica 100% vaccine is indicated.
Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0.
Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active.
Exclusion Criteria:
Patients who received immunotherapy in the previous 5 years for Parietaria judaica or fo rany allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1< 70% even if the are pharmacologically controlled .
Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.
Patients with a previous history of anaphylaxis
Patients with chronic urticaria,
Patients with moderate to severe atopic dermatitis
Patients who have participated in another clinical trial within 3 month prior to enrolment.
Patients under treatment with tricyclic antidepressives, phenothiazines , β-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
Female patients who are pregnant or breast-feeding
Patient who does not attend the visits
Patient's lack of collaboration or refusal to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Araitz Landeta
Organizational Affiliation
Roxall Medicina España S.A
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Vega Baja
City
Orihuela
State/Province
Alicante
ZIP/Postal Code
03314
Country
Spain
Facility Name
Hospital de Manises
City
Manises
State/Province
Valencia
Country
Spain
Facility Name
Hosptal de Sagunto
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Multicenter, Open Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica
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