Clinical trial NCT02477917: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rhinoconjunctivitis
Keywords: allergy
SCIT
Lead sponsor: Roxall Medicina España S.A
Sponsor class: INDUSTRY
First posted: 2015-06-23
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patients must sign the informed consent form.
2. Patients must be between 18 and 60 years of age.
3. 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).
4. Patients who obtained a prick test result ≥ 3 mm diameter to Parietaria judacia. Positive and negative control of the test should give consistent results.
5. Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to Parietaria judaica.
6. Patients sensitized to Parietaria judaica with clinically relevant symptoms in which treatment with Parietaria judaica 100% vaccine is indicated.
7. Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0.
8. Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active.

Exclusion Criteria:

1. 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.
2. Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1\< 70% even if the are pharmacologically controlled .
3. 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.
4. Patients with a previous history of anaphylaxis
5. Patients with chronic urticaria,
6. Patients with moderate to severe atopic dermatitis
7. Patients who have participated in another clinical trial within 3 month prior to enrolment.
8. Patients under treatment with tricyclic antidepressives, phenothiazines , β-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
9. Female patients who are pregnant or breast-feeding
10. Patient who does not attend the visits
11. Patient's lack of collaboration or refusal to participate.

Primary outcomes:
measure: Number and severity of adverse reactions as a measure of Safety and tolerability
timeFrame: across 17 weeks treatment period
Secondary outcomes:
measure: Immunoglobulin changes from baseline
timeFrame: At baseline and 1 week after last administered dose
measure: Skin reactivity changes from baseline
timeFrame: At baseline and 1 week after last administered dose
Other outcomes:
Locations:
city: Orihuela
country: Spain
facility: Hospital Vega Baja
state: Alicante
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
city: Sagunto
country: Spain
facility: Hosptal de Sagunto
state: Valencia
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
affiliation: Roxall Medicina España S.A
name: Araitz Landeta
role: STUDY_CHAIR
References: