Allergic Rhinitis Due to Olea Europaea PollenPhase 2/3NCT01674595
An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy
A Phase 2/3 study testing AVANZ olea in people with Allergic Rhinitis Due to Olea Europaea Pollen, run by ALK-Abelló A/S at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis Due to Olea Europaea Pollen
- What is being tested?
- AVANZ olea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2012to Apr 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- AVANZ olea
- Keywords
- Olea sensitization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVANZ oleaBiological
Immunotherapy Olea europaea
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy | Experimental | AVANZ Receives: Biological: AVANZ olea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for an expected average of 6 week.s
Secondary outcomes (1)
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.
Measured: Participants will be followed for an expected average of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic Rhinitis Due to Olea Europaea PollenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CARMEN MORENO, MD, Principal investigator, HOSPITAL UNIVERSITARIO REINA SOFÍA Córdoba- Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674595
- Sponsor's protocol ID
- AV-X-01
- Other IDs
- 2011-004852-20
- Status last verified
- Apr 2013
- First submitted
- 27 Aug 2012
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26213608
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy
- ClinicalTrials.gov ID
- NCT01674595
- Acronym / sponsor ID
- AV-X-01
- Keywords
- Olea sensitization
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy | Experimental | Biological: AVANZ oleaAVANZ |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVANZ oleaImmunotherapy Olea europaea | Biological | Immunotherapy |
Primary outcome
Frequency of patients with adverse reactions.
Time frame: Participants will be followed for an expected average of 6 week.s
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.
1 secondary outcome
Frequency of patients with systemic reactions according to EAACI classification.
Time frame: Participants will be followed for an expected average of 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
- Derived from this study: PubMed 26213608Moreno 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CARMEN MORENO, MD principal investigator
HOSPITAL UNIVERSITARIO REINA SOFÍA Córdoba- Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AVANZ olea in people with Allergic Rhinitis Due to Olea Europaea Pollen, run by ALK-Abelló A/S at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of patients with adverse reactions. (time frame: Participants will be followed for an expected average of 6 week.s). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01674595, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.