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

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ClinicalTrials.gov Identifier: NCT02849210
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
Roxall Medicina España S.A

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
Rhinoconjunctivitis 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
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 : September 2015
Actual Primary Completion Date : June 2, 2017
Actual Study Completion Date : June 2, 2017

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.




Primary Outcome Measures :
  1. Number and severity of adverse reactions as a measure of Safety and tolerability [ Time Frame: 17 weeks treatment period ]

Secondary Outcome Measures :
  1. Immunoglobulin changes from baseline [ Time Frame: At baseline and 1 week after last administered dose ]
  2. Cutaneous reactivity changes from baseline [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849210


Locations
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Spain
Complejo Hospitalario de Jaén
Jaén, Andalucía, Spain, 23007
Hospital Santa Bárbara
Puertollano, Ciudad Real, Spain
Hospital Infanta Cristina
Badajoz, Spain
Hospital Costa de la Luz
Huelva, Spain
Hospital Nisar Sevilla
Sevilla, Spain
Sponsors and Collaborators
Roxall Medicina España S.A
Investigators
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Study Chair: Maricruz Gómez Fernández, MD Roxall Medicina España S.A

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Responsible Party: Roxall Medicina España S.A
ClinicalTrials.gov Identifier: NCT02849210     History of Changes
Other Study ID Numbers: BIA-OLEA-DEPOT
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017