An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis Due to Olea Europaea Pollen
• Intervention / Treatment: Biological: AVANZ olea

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Spain
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. FEV1 < 70% of predicted value at screening after adequate pharmacologic treatment.
2. Uncontrolled or severe asthma.
3. 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.
4. History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
5. 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).
6. 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).
7. 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.
8. 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).
9. History of anaphylactic shock due to e.g. food, insect venom, exercise or drug.
10. History of severe and recurrent angioedema.
11. Any contraindication according to the Investigator Brochure (IB).
12. Use of an investigational drug within 30 days prior to screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Immunotherapy; AVANZ	Biological: AVANZ olea; Immunotherapy Olea europaea

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S
• Investigators: Principal Investigator: CARMEN MORENO, MD, HOSPITAL UNIVERSITARIO REINA SOFÍA Córdoba- Spain

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: August 27, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (ESTIMATE): August 29, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 30, 2013
• Last Update Submitted That Met QC Criteria: April 29, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Olea sensitization
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: AV-X-01; 2011-004852-20 (EUDRACT_NUMBER)