A Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Rhinoconjuncitivis Sensitized to Olea Europaea

A Phase I Multicenter, Open Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Rhinoconjuncitivis Sensitized to Olea Europaea

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

Study Overview

• Status: Completed
• Conditions: Rhinoconjunctivitis
• Intervention / Treatment: Biological: Allergovac depot with Olea europaea pollen extract

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain
    • Hospital Infanta Cristina
  • Huelva, Spain
    • Hospital Costa de la Luz
  • Sevilla, Spain
    • Hospital Nisar Sevilla
  • Andalucía
    • Jaén, Andalucía, Spain, 23007
      • Complejo Hospitalario de Jaen
  • Ciudad Real
    • Puertollano, Ciudad Real, Spain
      • Hospital Santa Bárbara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allergovac depot; Allergovac depot with Olea europaea pollen extract	Biological: Allergovac depot with Olea europaea pollen extract; Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly increasing dose injections at the initiation phase plus 3 maintenance monthly injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number and severity of adverse reactions as a measure of Safety and tolerability	17 weeks treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunoglobulin changes from baseline		At baseline and 1 week after last administered dose
Cutaneous reactivity changes from baseline	Skin prick test will be conducted at baseline and 1 week after last administered dose to measure the wheal área changes in mm2	At baseline and 1 week after last administered dose

Collaborators and Investigators

• Sponsor: Roxall Medicina España S.A
• Investigators: Study Chair: Maricruz Gómez Fernández, MD, Roxall Medicina España S.A

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): June 2, 2017
• Study Completion (Actual): June 2, 2017

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2017
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: BIA-OLEA-DEPOT