Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea PollenPhase 3OLEANCT00831025
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen
A Phase 3 study testing Immunotherapy with modified extract of Olea europaea pollen in people with Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen, run by Laboratorios Leti, S.L. at 7 sites in Spain.
Trial summary
The objective of this trial is to assess the clinical efficacy of a modified allergen extract of Olea europaea pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to olea europaea pollen, evaluating the Score regarding… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen
- What is being tested?
- Immunotherapy with modified extract of Olea europaea pollen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 7 sitesSpain
- Study dates
- Jan 2008to Jan 2013
- Phase
- Phase 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Prior to study specific examinations the patient and if applicable both legal guardians has to give his/her written informed consent
- Patients of both gender aged from 18 and 55 years
- Patient's perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS)
- FEV1 greater or equal than 80% of the expected value, and if not, improvement of FEV1 greater than 12% after bronchodilation
- Patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis with or without mild intermittent allergic asthma) caused by clinical sensitization against Olea europaea pollen. The IgE mediated sensitization has to be verified by:
- Suggestive medical history
- Specific IgE against Olea europaea pollen CAP RAST ≥0.7Ku/l
- Positive skin prick test (SPT) to grass Olea pollen resulting in a wheal diameter of at least 3 mm.
Who cannot join
- History of significant clinical manifestations of allergy as a result of sensitization against weed pollen allergens and perennial (e.g. house dust mite.
- Participation in an immunotherapy with comparable extracts within the last five years.
- Treatment with β-blocker
- Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
- Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
- Immunopathological diseases
- Patients who are expected to be non-compliant and/or not co-operative
- Women, where pregnancy is defined as the state of a female after conception and until the termination of gestation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Universitario Reina Sofía
Córdoba, 14004
Hospital El Tomillar
Dos Hermanas, Sevilla, 41700
Hospital Universitario San Cecilio
Granada, 18012
Complejo Hospitalario de Jaén
Jaén, 23007
Hospital Universitario Virgen Del Rocio
Seville, 41013
Clínica Santa Isabel
Seville, 41018
Hospital Virgen Macarena
Seville, 41071
About this study
Official title: Multicenter, Randomised, Double-blind Placebo-controlled, Subcutaneous Immunotherapy Clinical Trial With Depigmented and Polymerized Allergen Extract of Olea Europaea Pollen in Patients With Hypersensitivity to Olea Pollen
The objective of this trial is to assess the clinical efficacy of a modified allergen extract of Olea europaea pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to olea europaea pollen, evaluating the Score regarding Symptoms and consumption of the medication.
Read the detailed description
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo-controlled study with two arms of treatment: placebo and active.
- Being tested
- Immunotherapy with modified extract of Olea europaea pollen, Placebo
- Keywords
- Immunotherapy, Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy with modified extract of Olea europaea pollenBiological
Subcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment.
PlaceboBiological
Placebo for subcutaneous monthly administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Depigmented and polymerized allergen extract of Olea europaea pollen for subcutaneous injection. Receives: Biological: Immunotherapy with modified extract of Olea europaea pollen |
| 2 | Placebo comparator | Placebo for subcutaneous injection. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms and medication score
Measured: 2 years
Secondary outcomes (8)
Dose-response skin prick-test
Measured: 2 years
Medication score
Measured: 2 years
Rhinoconjunctivitis quality of life questionnaire
Measured: 2 years
Visual Analog Scales (VAS)
Measured: 2 years
Serology
Measured: 2 years
Symptoms score
Measured: 2 years
Exhaled nitric oxide
Measured: 2 years
Adverse event
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Leti, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Guardia, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831025
- Sponsor's protocol ID
- 6018-PG-PSC-148
- Other IDs
- 2006-005727-41
- Acronym
- OLEA
- Status last verified
- Feb 2018
- First submitted
- 27 Jan 2009
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomised, Double-blind Placebo-controlled, Subcutaneous Immunotherapy Clinical Trial With Depigmented and Polymerized Allergen Extract of Olea Europaea Pollen in Patients With Hypersensitivity to Olea Pollen
- ClinicalTrials.gov ID
- NCT00831025
- Acronym / sponsor ID
- OLEA / 6018-PG-PSC-148
- Keywords
- Immunotherapy, Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Jan 2009 (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.
The objective of this trial is to assess the clinical efficacy of a modified allergen extract of Olea europaea pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to olea europaea pollen, evaluating the Score regarding Symptoms and consumption of the medication.
Detailed description
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo-controlled study with two arms of treatment: placebo and active.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Immunotherapy with modified extract of Olea europaea pollenDepigmented and polymerized allergen extract of Olea europaea pollen for subcutaneous injection. |
| 2 | Placebo comparator | Biological: PlaceboPlacebo for subcutaneous injection. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Prior to study specific examinations the patient and if applicable both legal guardians has to give his/her written informed consent
- Patients of both gender aged from 18 and 55 years
- Patient's perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS)
- FEV1 greater or equal than 80% of the expected value, and if not, improvement of FEV1 greater than 12% after bronchodilation
- Patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis with or without mild intermittent allergic asthma) caused by clinical sensitization against Olea europaea pollen. The IgE mediated sensitization has to be verified by:
Key exclusion criteria (8 listed)
- History of significant clinical manifestations of allergy as a result of sensitization against weed pollen allergens and perennial (e.g. house dust mite.
- Participation in an immunotherapy with comparable extracts within the last five years.
- Treatment with β-blocker
- Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
- Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
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 |
|---|---|---|
| Immunotherapy with modified extract of Olea europaea pollenSubcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment. | Biological | 1 |
| PlaceboPlacebo for subcutaneous monthly administration | Biological | 2 |
Primary outcome
Symptoms and medication score
Time frame: 2 years
8 secondary outcomes
Dose-response skin prick-test
Time frame: 2 years
Medication score
Time frame: 2 years
Rhinoconjunctivitis quality of life questionnaire
Time frame: 2 years
Visual Analog Scales (VAS)
Time frame: 2 years
Serology
Time frame: 2 years
Symptoms score
Time frame: 2 years
Exhaled nitric oxide
Time frame: 2 years
Adverse event
Time frame: 2 years
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 23 Feb 2018.
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.
Pedro Guardia, MD principal investigator
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immunotherapy with modified extract of Olea europaea pollen in people with Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen, run by Laboratorios Leti, S.L. at 7 sites 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 8 inclusion and 8 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Symptoms and medication score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2018.