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CompletedNCT02849210Updated Oct 23, 2017

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

A Phase 1 interventional study of Allergovac depot with Olea europaea pollen extract in Rhinoconjunctivitis, sponsored by Roxall Medicina España S.A. Completed at 5 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-23.

Sponsored by Roxall Medicina España S.A · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Rhinoconjunctivitis
03

In context

Lead sponsor

Roxall Medicina España S.A is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    Allergovac depot

    Allergovac depot with Olea europaea pollen extract

    Biological: Allergovac depot with Olea europaea pollen extract

Interventions

  • BiologicalAllergovac 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.

06

What researchers measure

Primary outcomes

  1. Number and severity of adverse reactions as a measure of Safety and tolerability

    Time frame: 17 weeks treatment period

Secondary outcomes

  1. Immunoglobulin changes from baseline

    Time frame: At baseline and 1 week after last administered dose

  2. 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

    Time frame: At baseline and 1 week after last administered dose

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Study locations

5 sites
  • Complejo Hospitalario de Jaén
    Jaén, Andalucía 23007, Spain
  • Hospital Santa Bárbara
    Puertollano, Ciudad Real, Spain
  • Hospital Infanta Cristina
    Badajoz, Spain
  • Hospital Costa de la Luz
    Huelva, Spain
  • Hospital Nisar Sevilla
    Sevilla, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02849210
Lead sponsor
Roxall Medicina España S.A
Responsible party
Sponsor
First posted
Jul 29, 2016
Start date
Sep 2015
Primary completion
Jun 2, 2017
Completion
Jun 2, 2017
Last update
Oct 23, 2017

Study contacts

Maricruz Gómez Fernández, MD
study chair · Roxall Medicina España S.A

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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