Allergy to PollenPhase 2NCT01984541
To Determine the Minimum Amount of Artemisia Vulgaris Allergen Extract Producing a Positive Skin Reaction.
A Phase 2 study testing Artemisia vulgaris in people with Allergy to Pollen, run by Laboratorios Leti, S.L. at 2 sites in Spain.
Trial summary
The objective of this study is to determine the biological activity of Artemisia vulgaris allergen extract in histamine equivalent units (HEP) units, in order to be used as in-house reference preparation (IHRP). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergy to Pollen
- What is being tested?
- Artemisia vulgaris
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- Mar 2014to Sep 2014
- 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
- Positive clinical history of inhalatory allergy to Artemisia vulgaris. Subject has provided written informed consent, appropriately signed and dated by the subject.
- Subject can be male or female of any race and ethinic group. Age major or equal 18 years and ninor or equal 60 years at the study inclusion day.
- A positive prick test with a standardized commercially Artemisia vulgaris allergen extract (Wheal medium diameter ≤ 3mm or wheal area ≥ 7 mm2). The skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study.
- A positive test for specific IgE to Artemisia vulgaris (CAP-RAST major or equal to 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
- Allergy symptoms during the Artemisia vulgaris pollen season.
Who cannot join
- Immunotherapy in the past 5 years with an allergen extract Artemisia vulgaris or other allergen extract that may interfere with the allergene to be tested (for example: Helianthus annuus (sunflower) elatior Ambrosia eiator (ambrosia) or peach.
- Use of drugs that may interfere before and after with the skin reactions (for example: antihistamines).
- Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants, beta-blockers, corticosteroids (major 10 mg/daily of prednisone or equivalent).
- Women who are pregnant or breastfeeding period and women with positive pregnancy test at Visit 2, before skin prick test.
- Dermographism affecting the skin area at the test site at either study visit. Atopic dermatitis affecting the skin area at the test site at either study visit. Urticaria affecting the skin area at the test site at either study visit. Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.
- Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases, endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases. Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial.
- Patients with diseases or conditions that limit the use of adrenaline. Severe psychiatric, psychological or neurological disorders. Abuse of alcohol, drugs or medicines in the previous year. Subjects who have received anti-IgE (Omalizumab).
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Hospital de La Agencia Valenciana de Salud Vega Baja
Orihuela, Alicante, 03314
About this study
Official title: Biological Standardization of Artemisia Vulgaris Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP).
The objective of this study is to determine the biological activity of Artemisia vulgaris allergen extract in histamine equivalent units (HEP) units, in order to be used as in-house reference preparation (IHRP).
Read the detailed description
This is an open, unblinded and non-randomized biological assay. Tehe study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Four concentrations of Artemisia vulgaris allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.
- Conditions
- Allergy to Pollen
- Being tested
- Artemisia vulgaris
- Keywords
- Pollen
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemisia vulgarisBiological
Also called Four different concentrations of Artemisia vulgaris allergen extract, positive control and negative control
Four concentrations of Artemisia vulgaris allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Artemisia vulgaris allergen extract(four concentrations 10, 1, 0,1 y 0,01 mg/ml) Positive Control Negative Control Receives: Biological: Artemisia vulgaris |
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 immediate phase.
Measured: 15-20 min after aplication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy to 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
- 30 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
- NCT01984541
- Sponsor's protocol ID
- 6058-PR-PRI-200
- Other IDs
- 2013-001310-15
- Status last verified
- May 2013
- First submitted
- 8 Nov 2013
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Standardization of Artemisia Vulgaris Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP).
- ClinicalTrials.gov ID
- NCT01984541
- Acronym / sponsor ID
- 6058-PR-PRI-200
- Conditions
- Allergy to Pollen
- Keywords
- Pollen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Nov 2013 (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 study is to determine the biological activity of Artemisia vulgaris allergen extract in histamine equivalent units (HEP) units, in order to be used as in-house reference preparation (IHRP).
Detailed description
This is an open, unblinded and non-randomized biological assay. Tehe study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Four concentrations of Artemisia vulgaris allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.
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: Artemisia vulgarisArtemisia vulgaris allergen extract(four concentrations 10, 1, 0,1 y 0,01 mg/ml) Positive Control Negative Control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Positive clinical history of inhalatory allergy to Artemisia vulgaris. Subject has provided written informed consent, appropriately signed and dated by the subject.
- Subject can be male or female of any race and ethinic group. Age major or equal 18 years and ninor or equal 60 years at the study inclusion day.
- A positive prick test with a standardized commercially Artemisia vulgaris allergen extract (Wheal medium diameter ≤ 3mm or wheal area ≥ 7 mm2). The skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study.
- A positive test for specific IgE to Artemisia vulgaris (CAP-RAST major or equal to 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
- Allergy symptoms during the Artemisia vulgaris pollen season.
Key exclusion criteria (7 listed)
- Immunotherapy in the past 5 years with an allergen extract Artemisia vulgaris or other allergen extract that may interfere with the allergene to be tested (for example: Helianthus annuus (sunflower) elatior Ambrosia eiator (ambrosia) or peach.
- Use of drugs that may interfere before and after with the skin reactions (for example: antihistamines).
- Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants, beta-blockers, corticosteroids (major 10 mg/daily of prednisone or equivalent).
- Women who are pregnant or breastfeeding period and women with positive pregnancy test at Visit 2, before skin prick test.
- Dermographism affecting the skin area at the test site at either study visit. Atopic dermatitis affecting the skin area at the test site at either study visit. Urticaria affecting the skin area at the test site at either study visit. Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.
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 |
|---|---|---|
| Artemisia vulgarisAlso: Four different concentrations of Artemisia vulgaris allergen extract, positive control and negative controlFour concentrations of Artemisia vulgaris allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm. | Biological | 1 |
Primary outcome
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
Time frame: 15-20 min after aplication
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 5 Jan 2015.
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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 Artemisia vulgaris in people with Allergy to 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 5 inclusion and 7 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 5 Jan 2015. 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 immediate phase. (time frame: 15-20 min after aplication). 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 5 Jan 2015.