NCT00831025

Brief Summary

The objective of this trial is to assess the clinical efficacy of a modified allergen extract of Olea europaea pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to olea europaea pollen, evaluating the Score regarding Symptoms and consumption of the medication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

5 years

First QC Date

January 27, 2009

Last Update Submit

February 21, 2018

Conditions

Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen

Keywords

ImmunotherapyAllergoidDepigmentedPolymerizedAllergen-extractRhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Symptoms and medication score

    2 years

Secondary Outcomes (8)

  • Dose-response skin prick-test

    2 years

  • Medication score

    2 years

  • Rhinoconjunctivitis quality of life questionnaire

    2 years

  • Visual Analog Scales (VAS)

    2 years

  • Serology

    2 years

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Depigmented and polymerized allergen extract of Olea europaea pollen for subcutaneous injection.

Biological: Immunotherapy with modified extract of Olea europaea pollen

2

PLACEBO COMPARATOR

Placebo for subcutaneous injection.

Biological: Placebo

Interventions

Immunotherapy with modified extract of Olea europaea pollenBIOLOGICAL

Subcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment.

1
PlaceboBIOLOGICAL

Placebo for subcutaneous monthly administration

2

Eligibility Criteria

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

You may qualify if:

  • Prior to study specific examinations the patient and if applicable both legal guardians has to give his/her written informed consent
  • Patients of both gender aged from 18 and 55 years
  • Patient's perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS)
  • FEV1 greater or equal than 80% of the expected value, and if not, improvement of FEV1 greater than 12% after bronchodilation
  • Patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis with or without mild intermittent allergic asthma) caused by clinical sensitization against Olea europaea pollen. The IgE mediated sensitization has to be verified by:
  • Suggestive medical history
  • Specific IgE against Olea europaea pollen CAP RAST ≥0.7Ku/l
  • Positive skin prick test (SPT) to grass Olea pollen resulting in a wheal diameter of at least 3 mm.

You may not qualify if:

  • History of significant clinical manifestations of allergy as a result of sensitization against weed pollen allergens and perennial (e.g. house dust mite.
  • Participation in an immunotherapy with comparable extracts within the last five years.
  • Treatment with β-blocker
  • Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
  • Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
  • Immunopathological diseases
  • Patients who are expected to be non-compliant and/or not co-operative
  • Women, where pregnancy is defined as the state of a female after conception and until the termination of gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital El Tomillar

Dos Hermanas, Sevilla, 41700, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Universitario San Cecilio

Granada, 18012, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23007, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Clínica Santa Isabel

Seville, 41018, Spain

Location

Hospital Virgen Macarena

Seville, 41071, Spain

Location

MeSH Terms

Conditions

Rhinitis

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Pedro Guardia, 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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

ES(7)