An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy

Study Overview
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Brief Summary
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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.

Official Title
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An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy

Conditions
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Allergic Rhinitis Due to Olea Europaea Pollen

Intervention / Treatment
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* Biological: AVANZ olea


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunotherapy<br>AVANZ | Biological: AVANZ olea<br>* Immunotherapy Olea europaea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Participants will be followed for an expected average of 6 week.s | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Participants will be followed for an expected average of 6 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Olea sensitization