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

Sponsor
Roxall Medicina España S.A (Industry)
Overall Status
Completed
CT.gov ID
NCT02849210
Collaborator
(none)
47
Enrollment
5
Locations
1
Arm
21
Duration (Months)
9.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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 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

Condition or Disease Intervention/Treatment Phase
  • Biological: Allergovac depot with Olea europaea pollen extract
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Multicenter, Open Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Rhinoconjuncitivis Sensitized to Olea Europaea
Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Jun 2, 2017
Actual Study Completion Date :
Jun 2, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number and severity of adverse reactions as a measure of Safety and tolerability [17 weeks treatment period]

Secondary Outcome Measures

  1. Immunoglobulin changes from baseline [At baseline and 1 week after last administered dose]

  2. Cutaneous reactivity changes from baseline [At baseline and 1 week after last administered dose]

    Skin prick test will be conducted at baseline and 1 week after last administered dose to measure the wheal área changes in mm2

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
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:

  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Complejo Hospitalario de Jaén Jaén Andalucía Spain 23007
2 Hospital Santa Bárbara Puertollano Ciudad Real Spain
3 Hospital Infanta Cristina Badajoz Spain
4 Hospital Costa de la Luz Huelva Spain
5 Hospital Nisar Sevilla Sevilla Spain

Sponsors and Collaborators

  • Roxall Medicina España S.A

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roxall Medicina España S.A
ClinicalTrials.gov Identifier:
NCT02849210
Other Study ID Numbers:
  • BIA-OLEA-DEPOT
First Posted:
Jul 29, 2016
Last Update Posted:
Oct 23, 2017
Last Verified:
Oct 1, 2017

Study Results

No Results Posted as of Oct 23, 2017