RhinoconjuntivitisPhase 1NCT02849249
A Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Olea Europaea and Phleum Pratense
A Phase 1 study testing allergovac polimerized (100/100) in people with Rhinoconjuntivitis, run by Roxall Medicina España S.A at 5 sites in Spain.
Trial summary
The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea and Phleum pratense in patients with… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rhinoconjuntivitis
- What is being tested?
- allergovac polimerized (100/100)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 5 sitesSpain
- Study dates
- Sep 2015to Jun 2016
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must sign the Informed Consent Form.
- Patients must be between 18 and 60 years of age.
- Patients with seasonal allergic rhinoconjunctivitis produced by Phleum pratense and Olea europaea during at least 2 years prior to participating in the study. Although the pathology being studied is allergic rhinoconjunctivitis, patients who have concomitant mild or moderate asthma may be included.
- Patients who have had a skin prick test result ≥ 3 mm in diameter against Phleum pratense and Olea europaea.
- Patients who have specific IgE ≥ class 2 (CAP/PHADIA) to Phleum pratense and Olea europaea.
- Patients will preferably be polysensitized to Phleum pratense. Polysensitized patients to otherallergenic sources may only be included in the study if their other sensitizations are produced by:
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- Overlapping seasonal pollens which are cross-reactive with Phleum pratense and Olea europaea.
- Pollens whose seasons do not overlap with Phleum pratense or Olea europaea and which are not expected to produce symptoms during the study period.
- Other allergens which are not expected to produce symptoms during the study period.
- Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
- Furthermore, women of child-bearing potential must agree to use adequate contraceptive methods during this study if they are sexually active.
Who cannot join
- Patients who received immunotherapy in the previous 5 years for Phleum pratense and Olea europaea or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
- Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1< 70% even if the are pharmacologically controlled .
- Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.
- Patients with a previous history of anaphylaxis
- Patients with chronic urticaria,
- Patients with moderate to severe atopic dermatitis
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- Patients who have participated in another clinical trial within 3 month prior to enrolment.
- Patients under treatment with tricyclic antidepressives, phenothiazines , β- blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
- Female patients who are pregnant or breast-feeding
- Patient who does not attend the visits
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Clínico Granada
Granada, 18012
Hospital de Henares
Henares, Madrid
Hospital Virgen Macarena
Seville, 41009
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital de Zafra
Zafra, Badajoz, 06300
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled, Open Trial, Parallel Groups (1: 1), With Subcutaneous Polimerized Mix (100/100), in Patients With Rhinoconjunctivitis Sensitized to the Following Combination of Pollen: Timothy Grass and Olea Europaea, and Asministered by Different Schedules
The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea and Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
- Conditions
- Rhinoconjuntivitis
- Being tested
- allergovac polimerized (100/100)
- Keywords
- allergy, Immunotherapy, SCIT
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allergovac polimerized (100/100)Biological
Also called Allergovac Poliplus
Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.
| Study group | Role | What they receive |
|---|---|---|
| One day schedule | Active comparator | Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in one day schedule. The maintenance dose (0.5 mL) is reached in one day. Receives: Biological: allergovac polimerized (100/100) |
| Rapid schedule | Active comparator | Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in a rapid Schedule.The initation phase includes 3 weekly increasing doses till the maintenance dose of 0.5 mL is reached. Receives: Biological: allergovac polimerized (100/100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of adverse reactions as a measure of safety and tolerabitity
Measured: Across 12-15 weeks treatment period
Secondary outcomes (2)
Immunoglobulin changes from baseline
Subrogate efficacy
Measured: At baseline and 1 week after last administered dose
Skin reactivity changes from baseline
Subrogate efficacy parameter. The patients will undergo a skin prick test at baseline and 1 week after last administered dose. The wheal are in mm2 will be measured and the results of both time frames will be compared.
Measured: At baseline and 1 week after last administered dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoconjuntivitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxall Medicina España S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- María C Gómez, Dr., Study director, Roxall Medicina España S.A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849249
- Sponsor's protocol ID
- BIA-OLEAPHL-POLI-100
- Status last verified
- Apr 2017
- First submitted
- 22 Jul 2016
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled, Open Trial, Parallel Groups (1: 1), With Subcutaneous Polimerized Mix (100/100), in Patients With Rhinoconjunctivitis Sensitized to the Following Combination of Pollen: Timothy Grass and Olea Europaea, and Asministered by Different Schedules
- ClinicalTrials.gov ID
- NCT02849249
- Acronym / sponsor ID
- BIA-OLEAPHL-POLI-100
- Conditions
- Rhinoconjuntivitis
- Keywords
- allergy, Immunotherapy, SCIT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Roxall Medicina España S.AIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Jul 2016 (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 study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea and Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One day schedule | Active comparator | Biological: allergovac polimerized (100/100)Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in one day schedule. The maintenance dose (0.5 mL) is reached in one day. |
| Rapid schedule | Active comparator | Biological: allergovac polimerized (100/100)Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in a rapid Schedule.The initation phase includes 3 weekly increasing doses till the maintenance dose of 0.5 mL is reached. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patients must sign the Informed Consent Form.
- Patients must be between 18 and 60 years of age.
- Patients with seasonal allergic rhinoconjunctivitis produced by Phleum pratense and Olea europaea during at least 2 years prior to participating in the study. Although the pathology being studied is allergic rhinoconjunctivitis, patients who have concomitant mild or moderate asthma may be included.
- Patients who have had a skin prick test result ≥ 3 mm in diameter against Phleum pratense and Olea europaea.
- Patients who have specific IgE ≥ class 2 (CAP/PHADIA) to Phleum pratense and Olea europaea.
Key exclusion criteria (10 listed)
- Patients who received immunotherapy in the previous 5 years for Phleum pratense and Olea europaea or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
- Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1< 70% even if the are pharmacologically controlled .
- Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.
- Patients with a previous history of anaphylaxis
- Patients with chronic urticaria,
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 |
|---|---|---|
| allergovac polimerized (100/100)Also: Allergovac PoliplusPatients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine. | Biological | One day schedule, Rapid schedule |
Primary outcome
Number and severity of adverse reactions as a measure of safety and tolerabitity
Time frame: Across 12-15 weeks treatment period
2 secondary outcomes
Immunoglobulin changes from baseline
Time frame: At baseline and 1 week after last administered dose
Skin reactivity changes from baseline
Time frame: At baseline and 1 week after last administered dose
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 1 May 2017.
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.
María C Gómez, Dr. study director
Roxall Medicina España S.A
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing allergovac polimerized (100/100) in people with Rhinoconjuntivitis, run by Roxall Medicina España S.A at 5 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 11 inclusion and 10 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 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number and severity of adverse reactions as a measure of safety and tolerabitity (time frame: Across 12-15 weeks treatment period). 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 1 May 2017.