Allergy to Grass Pollen (Secale Cereale)Phase 2NCT01408238
Biological Standardization of Secale Cereale Allergen Extract
A Phase 2 study of Allergy to Grass Pollen (Secale Cereale), 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 Secale cereale 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 (Secale Cereale)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2011to Jun 2012
- 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 Secale cereale 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 Secale cereale (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 Secale cereale.
- 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.
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- Urticaria affecting the skin area at the test site at either study visit.
- Participation in another clinical trial within the last month.
- Subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension, ..)
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario La Paz
Madrid, Madrid / Madrid, 28046
Hospital Universitario Virgen Macarena
Seville, Sevilla / Andalucía, 41009
About this study
Official title: Biological Standardization of Secale Cereale Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units
The objective of this study is to determine the biologic activity of a Secale cereale allergen extract in histamine equivalent prick (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. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Four concentrations of Secale cereale 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 (Secale Cereale)
- Being tested
- Four different concentrations of Secale cereale allergen extract, positive control and negative control
- Keywords
- Immunotherapy, Skin prick test, Standardization, Secale cereale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four different concentrations of Secale cereale allergen extract, positive control and negative controlBiological
4 concentrations of Secale cereale 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 | * Secale cereale allergen extract at 4 different concentrations
* Positive control
* Negative control Receives: Biological: Four different concentrations of Secale cereale allergen extract, positive control and negative control |
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: 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 posted3 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy to Grass Pollen (Secale Cereale)Studies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 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.Unipersonal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408238
- Sponsor's protocol ID
- 6049-PR-PRI-184
- Other IDs
- 2010-023951-27
- Status last verified
- Aug 2012
- First submitted
- 1 Aug 2011
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Standardization of Secale Cereale Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units
- ClinicalTrials.gov ID
- NCT01408238
- Acronym / sponsor ID
- 6049-PR-PRI-184
- Conditions
- Allergy to Grass Pollen (Secale Cereale)
- Keywords
- Immunotherapy, Skin prick test, Standardization, Secale cereale
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Aug 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 Secale cereale allergen extract in histamine equivalent prick (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. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Four concentrations of Secale cereale 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Four different concentrations of Secale cereale allergen extract, positive control and negative control* Secale cereale allergen extract at 4 different concentrations * Positive control * Negative control |
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 Secale cereale 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 Secale cereale (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 (9 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 |
|---|---|---|
| Four different concentrations of Secale cereale allergen extract, positive control and negative control4 concentrations of Secale cereale 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: 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 9 Aug 2012.
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.Unipersonal
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 of Allergy to Grass Pollen (Secale Cereale), 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 9 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 9 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: 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 9 Aug 2012.