Allergy to Tree PollenPhase 2NCT02512653
Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)
A Phase 2 study testing Cupressus arizonica in people with Allergy to Tree Pollen, run by Laboratorios Leti, S.L. at 2 sites in Spain.
Trial summary
Biological Standardization of Cupressus arizonica Allergen Extract. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergy to Tree Pollen
- What is being tested?
- Cupressus arizonica
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesSpain
- Study dates
- Nov 2015to Jan 2016
- Phase
- Phase 2
- 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
- Subject has provided written informed consent, appropriately signed and dated by subject.
- Subject can be male or female of any race and ethinic group.
- Age 18 years and 60 years ata the study inclusión day.
- Positive clinical history of inhalatory allergy to Cupressus arizonica.
- A positive prick test with a standarices commercially Cupressus arizonica allergen extract.
- A positive prick test with positive control of histamine 10 mg/ml.
- A positive test for specific IgE to Cupressus arizonica.
Who cannot join
- Immunotherapy in the past 5 years with an allergen extract Cupressus arizonca or other allergen extract than may interfere with the allergene to be tested.
- Use of drugs that may interfere before and after with the skin reactions.
- Treatment with certain drugs.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario de Fuenlabrada
Fuenalabrada, Madrid, 28942
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
About this study
Biological Standardization of Cupressus arizonica Allergen Extract.
Read the detailed description
This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
- Conditions
- Allergy to Tree Pollen
- Being tested
- Cupressus arizonica
- Keywords
- Allergy to Cupressus pollen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cupressus arizonicaBiological
Four different concentrations of Cupressus arizonica allergen extract, positive control and negative control
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cupressus arizonica allergen extract at 4 different concentrations. Positive control. Negative control Receives: Biological: Cupressus arizonica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheal size area (mm2) on the skin at the site of the puncture during the inmediate phase
Measured: Test sites should be inspected and recorded 15-20 min after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy to Tree 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Leti, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lena Erbiti, Study chair, Laboratorios Leti, S.L.U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512653
- Sponsor's protocol ID
- 608-PR-PRI-199
- Status last verified
- Jun 2016
- First submitted
- 29 Jul 2015
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)
- ClinicalTrials.gov ID
- NCT02512653
- Acronym / sponsor ID
- 608-PR-PRI-199
- Conditions
- Allergy to Tree Pollen
- Keywords
- Allergy to Cupressus pollen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 31 Jul 2015 (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.
Biological Standardization of Cupressus arizonica Allergen Extract.
Detailed description
This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Cupressus arizonicaCupressus arizonica allergen extract at 4 different concentrations. Positive control. Negative control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject has provided written informed consent, appropriately signed and dated by subject.
- Subject can be male or female of any race and ethinic group.
- Age 18 years and 60 years ata the study inclusión day.
- Positive clinical history of inhalatory allergy to Cupressus arizonica.
- A positive prick test with a standarices commercially Cupressus arizonica allergen extract.
Key exclusion criteria (3 listed)
- Immunotherapy in the past 5 years with an allergen extract Cupressus arizonca or other allergen extract than may interfere with the allergene to be tested.
- Use of drugs that may interfere before and after with the skin reactions.
- Treatment with certain drugs.
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 |
|---|---|---|
| Cupressus arizonicaFour different concentrations of Cupressus arizonica allergen extract, positive control and negative control | Biological | 1 |
Primary outcome
Wheal size area (mm2) on the skin at the site of the puncture during the inmediate phase
Time frame: Test sites should be inspected and recorded 15-20 min after application
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 20 Jun 2016.
Related trials for Allergy to Tree Pollen
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Active, not recruitingObservational study
Tyrosine Allergoid Paediatric and Adult Study
Allergic Rhinitis Due to Pollen, Allergic Conjunctivitis
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.
Lena Erbiti study chair
Laboratorios Leti, S.L.U
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cupressus arizonica in people with Allergy to Tree Pollen, run by Laboratorios Leti, S.L. at 2 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 7 inclusion and 3 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 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Wheal size area (mm2) on the skin at the site of the puncture during the inmediate phase (time frame: Test sites should be inspected and recorded 15-20 min after application). 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 20 Jun 2016.