Allergy to Grass PollenPhase 2NCT01394289
Biological Standardization of Lolium Perenne Allergen Extract
A Phase 2 study testing Lolium allergen extract in people with Allergy to Grass Pollen, run by Laboratorios Leti, S.L. at 2 sites in Spain.
Trial summary
The objective of this study is to determine the biologic activity of a Lolium perenne allergen extract in histamine equivalent prick (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 50 years
- Conditions the study is for
- Allergy to Grass Pollen
- What is being tested?
- Lolium allergen extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2011to Nov 2011
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
- Subject can be male or female of any race and ethnic group.
- Age > 18 years and < 50 years at the study inclusion day.
- Positive skin prick test with a standardized commercially available preparation of Lolium perenne allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. Positive 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 Lolium perenne (CAP-RAST ≥ 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
- Allergic symptoms during the pollen season of Lolium perenne.
- Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm.
Who cannot join
- Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., grass group extracts).
- Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1
- Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (> 10 mg/day of prednisone or equivalent).
- Pregnancy.
- 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.
- Participation in another clinical trial within the last month.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario de Salamanca
Salamanca, Salamanca, 37007
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
About this study
Official title: Biological Standardization of Lolium Perenne Allergen Extract to Determine the Biological Activity in HEP Units
The objective of this study is to determine the biologic activity of a Lolium perenne allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
Read the detailed description
Four concentrations of Lolium perenne 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 Grass Pollen
- Being tested
- Lolium allergen extract
- Keywords
- Standardization, Immunotherapy, Skin prick test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lolium allergen extractBiological
This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.
Four concentrations of Lolium perenne 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. This test will be referred to as the Titrated Skin Prick test.
| Study group | Role | What they receive |
|---|---|---|
| Biological/Vaccine: Lolium allergen extract | Experimental | Four concentrations of Lolium perenne 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. This test will be referred to as the Titrated Skin Prick test. Receives: Biological: Lolium allergen extract |
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: 30 minutes per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy to Grass 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Leti, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- María José Gómez, Study chair, Laboratorios LETI, S.L.U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394289
- Sponsor's protocol ID
- 6041-PR-PRI-182
- Other IDs
- 2010-023949-29
- Status last verified
- Aug 2011
- First submitted
- 13 Jul 2011
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Standardization of Lolium Perenne Allergen Extract to Determine the Biological Activity in HEP Units
- ClinicalTrials.gov ID
- NCT01394289
- Acronym / sponsor ID
- 6041-PR-PRI-182
- Conditions
- Allergy to Grass Pollen
- Keywords
- Standardization, Immunotherapy, Skin prick test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 Jul 2011 (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 biologic activity of a Lolium perenne allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
Detailed description
Four concentrations of Lolium perenne 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 |
|---|---|---|
| Biological/Vaccine: Lolium allergen extract | Experimental | Biological: Lolium allergen extractFour concentrations of Lolium perenne 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. This test will be referred to as the Titrated Skin Prick test. |
Who may qualify
- Ages
- 18 to 50 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 the subject (or legal representative, if applicable).
- Subject can be male or female of any race and ethnic group.
- Age > 18 years and < 50 years at the study inclusion day.
- Positive skin prick test with a standardized commercially available preparation of Lolium perenne allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. Positive 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 Lolium perenne (CAP-RAST ≥ 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
Key exclusion criteria (8 listed)
- Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., grass group extracts).
- Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1
- Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (> 10 mg/day of prednisone or equivalent).
- Pregnancy.
- Dermographism affecting the skin area at the test site at either study visit.
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 |
|---|---|---|
| Lolium allergen extractThis is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines. Four concentrations of Lolium perenne 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. This test will be referred to as the Titrated Skin Prick test. | Biological | Biological/Vaccine: Lolium allergen extract |
Primary outcome
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
Time frame: 30 minutes per subject
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 27 Aug 2012.
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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.
María José Gómez 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 Lolium allergen extract in people with Allergy to Grass 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 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 27 Aug 2012. 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: 30 minutes per subject). 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 27 Aug 2012.