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An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy

Primary Purpose

Allergic Rhinitis Due to Olea Europaea Pollen

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

AVANZ olea

About this trial

This is an interventional treatment trial for Allergic Rhinitis Due to Olea Europaea Pollen focused on measuring Olea sensitization

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female patients 18-65 years of age.
A clinical history of olive pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
Positive SPT to olive pollen (wheal diameter ≥ 3 mm).
A positive specific IgE against olive pollen (≥Class 2; ≥0.70 KU/L) documented in the last 5 y

Exclusion Criteria:

FEV1 < 70% of predicted value at screening after adequate pharmacologic treatment.
Uncontrolled or severe asthma.
A clinically relevant history of symptomatic perennial allergic rhinitis and/or conjunctivitis caused by an allergen to which the subject is regularly exposed and sensitized.
History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion).
Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication).
Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, β-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis.
Previous treatment by other allergen concomitant IT or immunotherapy with Olea europaea extracts within the previous 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted).
History of anaphylactic shock due to e.g. food, insect venom, exercise or drug.
History of severe and recurrent angioedema.
Any contraindication according to the Investigator Brochure (IB).
Use of an investigational drug within 30 days prior to screening.

Sites / Locations

Hospital Universitario Reina Sofía

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Immunotherapy

Arm Description

AVANZ

Outcomes

Primary Outcome Measures

Frequency of patients with adverse reactions.

From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject.

Secondary Outcome Measures

Frequency of patients with systemic reactions according to EAACI classification.

From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject.

Full Information

NCT ID

NCT01674595

First Posted

August 27, 2012

Last Updated

April 29, 2013

Sponsor

ALK-Abelló A/S

1. Study Identification

Unique Protocol Identification Number

NCT01674595

Brief Title

An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy

Official Title

An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ALK-Abelló A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is an open, national, multi-centre trial. The trial will be initiated after olive pollen season 2012 and subjects will receive treatment for 6 weeks. The aim of study is to assess the tolerability of the up-dosing phase of AVANZ Olive. The frequency of patients with adverse reactions will be the primary endpoint. Frequency of patients with systemic reactions according to EAACI classification, increase in IgG4 and in IgE and reduction in immediate skin reactivity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis Due to Olea Europaea Pollen

Keywords

Olea sensitization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immunotherapy

Arm Type

Experimental

Arm Description

AVANZ

Intervention Type

Biological

Intervention Name(s)

AVANZ olea

Intervention Description

Immunotherapy Olea europaea

Primary Outcome Measure Information:

Title

Frequency of patients with adverse reactions.

Description

From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject.

Time Frame

Participants will be followed for an expected average of 6 week.s

Secondary Outcome Measure Information:

Title

Frequency of patients with systemic reactions according to EAACI classification.

Description

From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject.

Time Frame

Participants will be followed for an expected average of 6 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients 18-65 years of age. A clinical history of olive pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry. Positive SPT to olive pollen (wheal diameter ≥ 3 mm). A positive specific IgE against olive pollen (≥Class 2; ≥0.70 KU/L) documented in the last 5 y Exclusion Criteria: FEV1 < 70% of predicted value at screening after adequate pharmacologic treatment. Uncontrolled or severe asthma. A clinically relevant history of symptomatic perennial allergic rhinitis and/or conjunctivitis caused by an allergen to which the subject is regularly exposed and sensitized. History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months. At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion). Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication). Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, β-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis. Previous treatment by other allergen concomitant IT or immunotherapy with Olea europaea extracts within the previous 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted). History of anaphylactic shock due to e.g. food, insect venom, exercise or drug. History of severe and recurrent angioedema. Any contraindication according to the Investigator Brochure (IB). Use of an investigational drug within 30 days prior to screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

CARMEN MORENO, MD

Organizational Affiliation

HOSPITAL UNIVERSITARIO REINA SOFÍA Córdoba- Spain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario Reina Sofía

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

26213608

Citation

Moreno C, De San Pedro BS, Millan C, Panizo C, Martin S, Florido F. Exploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea. Clin Transl Allergy. 2015 Jul 24;5:27. doi: 10.1186/s13601-015-0070-y. eCollection 2015.

Results Reference

derived

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An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy

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