NCT00537342

Brief Summary

The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Olea europaea in the rhinitis or allergic rhinoconjunctivitis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 17, 2010

Status Verified

December 1, 2010

Enrollment Period

1.9 years

First QC Date

September 28, 2007

Last Update Submit

December 16, 2010

Conditions

AllergyRhinoconjunctivitis

Keywords

ImmunotherapyAllergoidDepigmentedPolymerizedAllergen-extractRhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Symptom score

    1 year

Secondary Outcomes (6)

  • Dose-response skin prick-test

    1 year

  • Medication score

    1 year

  • Rhinoconjunctivitis quality of life questionnaire

    1 year

  • Analogical visual scale

    1 year

  • Serology

    1 year

  • +1 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Biological Vaccine

Biological: Immunotherapy with modified extract of O. europaea pollen

B

PLACEBO COMPARATOR
Biological: Immunotherapy with modified extract of O. europaea pollen

Interventions

Immunotherapy with modified extract of O. europaea pollenBIOLOGICAL

Sublingual (2 drops daily during 2 months)

AB

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive suggestive clinical history of allergic seasonal rhinitis or rhinoconjunctivitis
  • Patients of both gender \> 18 years old
  • Positive prick test results using non modified Olea europaea allergen extract (wheal size \> 3mm2)
  • Specific IgE to Olea europaea
  • Written informed consent

You may not qualify if:

  • Use of immunotherapy during the last four years.
  • Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
  • Treatment with ß-blockers
  • Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
  • Patients suffering from immune deficiencies
  • Patients with serious psychiatric / psychological disturbances
  • Pregnant or/ in lactation patients
  • Patients aspirin intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitatio Ciudad de Jaén

Jaén, Jaén, 23007, Spain

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Juan Luis Anguita, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 28, 2007

First Posted

October 1, 2007

Study Start

October 1, 2007

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

December 17, 2010

Record last verified: 2010-12

Locations

ES(1)