An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy
NCT ID: NCT01674595
Last Updated: 2013-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
93 participants
INTERVENTIONAL
2012-09-30
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immunotherapy
AVANZ
AVANZ olea
Immunotherapy Olea europaea
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AVANZ olea
Immunotherapy Olea europaea
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ALK-Abelló A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
CARMEN MORENO, MD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL UNIVERSITARIO REINA SOFÍA Córdoba- Spain
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-004852-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AV-X-01
Identifier Type: -
Identifier Source: org_study_id