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

NCT02849210 | Completed Phase 1

• 1 other identifier: BIA-OLEA-DEPOT
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 5

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

Conditions

Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Number and severity of adverse reactions as a measure of Safety and tolerability

  17 weeks treatment period

Secondary Outcomes (2)

• Immunoglobulin changes from baseline

  At baseline and 1 week after last administered dose

• Cutaneous reactivity changes from baseline

  At baseline and 1 week after last administered dose

Study Arms (1)

Allergovac depot

EXPERIMENTAL

Allergovac depot with Olea europaea pollen extract

Biological: Allergovac depot with Olea europaea pollen extract

Interventions

Allergovac depot with Olea europaea pollen extract BIOLOGICAL

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.

Allergovac depot

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must sign the informed consent form.
• Patients must be between 18 and 60 years of age.
• Patients who obtained a prick test result ≥ 3 mm diameter to Olea europaea Positive and negative control of the test should give consistent results.
• Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to Olea europaea.
• Patients sensitized to Olea europaea with clinically relevant symptoms in which treatment with Olea europea 100% vaccine is indicated.
• Patients who met all windows of treatment described in the protocol for both, treatment and study procedures.
• Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0.
• Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active.

You may not qualify if:

• 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.
• Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1\< 70% even if the are pharmacologically controlled .
• 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.
• 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
• Patients with a previous history of anaphylaxis
• Patients with chronic urticaria,
• Patients with moderate to severe atopic dermatitis
• Patients who have participated in another clinical trial within 3 month prior to enrolment.
• Patients under treatment with tricyclic antidepressives, phenothiazines , β-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
• Female patients who are pregnant or breast-feeding
• Patient who does not attend the visits
• Patient's lack of collaboration or refusal to participate.

Sponsors & Collaborators

• Roxall Medicina España S.A: lead

Study Sites (5)

Complejo Hospitalario de Jaén

Jaén, Andalusia, 23007, Spain

Location

Hospital Santa Bárbara

Puertollano, Ciudad Real, Spain

Location

Hospital Infanta Cristina

Badajoz, Spain

Location

Hospital Costa de la Luz

Huelva, Spain

Location

Hospital Nisar Sevilla

Seville, Spain

Location

Study Officials

• Maricruz Gómez Fernández, MD

  Roxall Medicina España S.A

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 29, 2016
• Study Start: September 1, 2015
• Primary Completion: June 2, 2017
• Study Completion: June 2, 2017
• Last Updated: October 23, 2017

Record last verified: 2017-10

Locations

ES (5)