Clinical trial NCT02849210: A Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Rhinoconjuncitivis Sensitized to Olea Europaea
Official title: A Phase I Multicenter, Open Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Rhinoconjuncitivis Sensitized to Olea Europaea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rhinoconjunctivitis
Lead sponsor: Roxall Medicina España S.A
Sponsor class: INDUSTRY
First posted: 2016-07-29
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_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 Olea europaea 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: An study conducted througout Spain with 4000 allergic patients (Alergoloógica 2005) showed that 47% of patients with rhinoconjuncitivits and 51% of asthmatic patients were sentitized to olive pollen. This gives us an idea of the importance of this allergen sensitization in Spain.

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 Olea europea 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.
4. Patients who obtained a prick test result ≥ 3 mm diameter to Olea europaea Positive and negative control of the test should give consistent results.
5. Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to Olea europaea.
6. Patients sensitized to Olea europaea with clinically relevant symptoms in which treatment with Olea europea 100% vaccine is indicated.
7. Patients who met all windows of treatment described in the protocol for both, treatment and study procedures.
8. Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0.
9. 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 Olea europaea or for any 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. Polisensitized patients to other inhalant allergens besides Olea europaea, if in the judgment of the investigator may present symptoms clinically relevant to those other airborne allergens while participating in this study
5. Patients with a previous history of anaphylaxis
6. Patients with chronic urticaria,
7. Patients with moderate to severe atopic dermatitis
8. Patients who have participated in another clinical trial within 3 month prior to enrolment.
9. Patients under treatment with tricyclic antidepressives, phenothiazines , β-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
10. Female patients who are pregnant or breast-feeding
11. Patient who does not attend the visits
12. 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: 17 weeks treatment period
Secondary outcomes:
measure: Immunoglobulin changes from baseline
timeFrame: At baseline and 1 week after last administered dose
measure: Cutaneous reactivity changes from baseline
timeFrame: At baseline and 1 week after last administered dose
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
state: Andalucía
city: Puertollano
country: Spain
facility: Hospital Santa Bárbara
state: Ciudad Real
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Huelva
country: Spain
facility: Hospital Costa de la Luz
city: Sevilla
country: Spain
facility: Hospital Nisar Sevilla
Study officials:
affiliation: Roxall Medicina España S.A
name: Maricruz Gómez Fernández, MD
role: STUDY_CHAIR
References: