Sensitization to AllergensPhase 1NCT01567319
Biological Standardization of D. Glomerata, L. Perenne, S. Cereale and O. Europaea Pollen Extracts
A Phase 1 study testing Skin Prick Test, Skin Prick Test - Atopic Subjects and Skin Prick Test - No Atopic Subjects in people with Sensitization to Allergens, run by Roxall Medicina España S.A at 7 sites in Spain.
Trial summary
Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. Many factors such as the biovariability, differences in extraction process and subsequent handling of allergens can affect the final composition, potency, and stability of allergen preparations. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitization to Allergens
- What is being tested?
- Skin Prick Test, Skin Prick Test - Atopic Subjects and Skin Prick Test - No Atopic Subjects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 7 sitesSpain
- Study dates
- Feb 2012to Nov 2012
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects sensitized to one or more allergen extracts:
- Positive clinical history with inhalant allergy to at least one of the allergen to be standardized.
- At least one positive prick test (mean wheal diameter greater or equal than 3mm) .
- Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml
- Age: 18-60 years
- Written informed consent
Show all 20Show fewer
- Patients will preferably be monosensitized, or with clinically relevant sensitization , or with primary sensitization (maximum cutaneous reactivity) to the extracts under investigation.
- Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
- Atopic Subjects:
- Age: 18-60 years
- Written informed consent
- Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml
- Negative prick test (mean wheal diameter less or equal to 3mm) when tested with already standardized extracts of the allergens under investigation or with cross reactive extracts.
- Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
- No Atopic Subjects:
- Age: 18-60 years.
- Written informed consent
- Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml
- Negative prick test (mean wheal diameter less or equal to 3mm)to all allergens tested in diagnostic prick test.
- Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
Who cannot join
- Immunotherapy in the 2 years prior to the study against either the allergen to be tested or an allergen which is cross-reactive. (it is not applicable to no atopic patients)
- Any drug which may interfere with the cutaneous test or with its result.
- Any medical condition that from investigator's point of view the skin prick test cannot be done .
- Women who are pregnant or breast-feeding or are child-bearing age and who have not demonstrated that they have been surgically sterilized or have other means of not bearing children.
- 4.Subjects who have participated in another clinical trial within 3 months prior to this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Universitario Infanta Cristina
Badajoz
Hospital Universitario Reina Sofía
Córdoba
Hospital Universitario de Guadalajara
Guadalajara
Complejo Hospitalario de Jaén
Jaén
Hospital General Universitario Gregorio Marañón
Madrid
Hospital de Manises
Manises, Valencia
Hospital Clínico Universitario Lozano Blesa
Zaragoza
About this study
Official title: Biological Standardization of D. Glomerata, L. Perenne, S. Cereale and O. Europaea Pollen Extracts in Patients Sensitized to Them.
Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. Many factors such as the biovariability, differences in extraction process and subsequent handling of allergens can affect the final composition, potency, and stability of allergen preparations. Genetic diversity of affected people adds another level of complexity. In order to control variability and to achieve consistency and reproducibility for optimal safety and sensitivity/specificity, it is essential to standardize the amount of allergen used in prick tests. Therefore, the system for biological standardization mainly used in Europe still is the biological calibration of in-House Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT) value. The aim of this procedure is to estimate the biological activity of allergen extracts. The activity of an allergen extract is defined as 1 SPT per ml, when the extract provokes a specific skin reaction with a wheal of the same size as a wheal provoked by reference histamine at a concentration of 10 mg/ml, when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are sensitized to the allergen concerned.
The present study aims to standardize the allergen extracts of Dactylis glomerata, Lolium perenne, Secale cereale y Olea europaea by using this method.
- Conditions
- Sensitization to Allergens
- Being tested
- Skin Prick Test, Skin Prick Test - Atopic Subjects, Skin Prick Test - No Atopic Subjects
- Keywords
- Sensitization, Skin Prick Test, Standardization, sources of: D. glomerata, L. perenne, S. cereale and O. europaea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Prick TestBiological
Skin prick test of 4 concentrations of each allergenic source, 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. Assessment of the wheal size after 15 minutes.
Skin Prick Test - Atopic SubjectsBiological
Skin prick test of 4 concentrations of each allergenic source,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. Assessment of the wheal size after 15 minutes.
Skin Prick Test - No Atopic SubjectsBiological
Skin prick test of 4 concentrations of each allergenic source, 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 subjects in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Allergic Subjects | Experimental | Not described Receives: Biological: Skin Prick Test |
| Atopic Subjects | Active comparator | Patients sensitized to other allergenic sources but the allergen extracts under investigation. Receives: Biological: Skin Prick Test - Atopic Subjects |
| No Atopic Subjects | Active comparator | Healthy volunteers. Receives: Biological: Skin Prick Test - No Atopic Subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheal size area
The primary efficacy variable will be the wheal size area at the site of the puncture of the immediate phase reaction in mm2.
Measured: 15 minutes after skin prick test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitization to AllergensStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxall Medicina España S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arantza Vega, MD, Principal investigator, University of GuadalajaraPilar Alba, MD, Principal investigator, Hospital de ManisesJosé Manuel Zubeldia, MD, Principal investigator, Hospital Universitario Gregorio MarañónMaría Ángeles Gonzalo Garijo, MD, Principal investigator, Hospital Universitario Infanta CristinaCarlos Colás, MD, Principal investigator, Hospital Clínico Universitario Lozano BlesaBlanca Saenz de San Pedro, Principal investigator, Complejo Hospitalario de JaénLourdes Fernández, MD, Principal investigator, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567319
- Sponsor's protocol ID
- BIA-STD-002
- Other IDs
- 2011-001270-25
- Status last verified
- Apr 2017
- First submitted
- 26 Mar 2012
- 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
- Biological Standardization of D. Glomerata, L. Perenne, S. Cereale and O. Europaea Pollen Extracts in Patients Sensitized to Them.
- ClinicalTrials.gov ID
- NCT01567319
- Acronym / sponsor ID
- BIA-STD-002
- Conditions
- Sensitization to Allergens
- Keywords
- Sensitization, Skin Prick Test, Standardization, sources of: D. glomerata, L. perenne, S. cereale and O. europaea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Roxall Medicina España S.AIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Mar 2012 (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.
Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. Many factors such as the biovariability, differences in extraction process and subsequent handling of allergens can affect the final composition, potency, and stability of allergen preparations. Genetic diversity of affected people adds another level of complexity. In order to control variability and to achieve consistency and reproducibility for optimal safety and sensitivity/specificity, it is essential to standardize the amount of allergen used in prick tests. Therefore, the system for biological standardization mainly used in Europe still is the biological calibration of in-House Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT) value. The aim of this procedure is to estimate the biological activity of allergen extracts. The activity of an allergen extract is defined as 1 SPT per ml, when the extract provokes a specific skin reaction with a wheal of the same size as a wheal provoked by reference histamine at a concentration of 10 mg/ml, when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are sensitized to the allergen concerned.
The present study aims to standardize the allergen extracts of Dactylis glomerata, Lolium perenne, Secale cereale y Olea europaea by using this method.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allergic Subjects | Experimental | Biological: Skin Prick Test |
| Atopic Subjects | Active comparator | Biological: Skin Prick Test - Atopic SubjectsPatients sensitized to other allergenic sources but the allergen extracts under investigation. |
| No Atopic Subjects | Active comparator | Biological: Skin Prick Test - No Atopic SubjectsHealthy volunteers. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Subjects sensitized to one or more allergen extracts:
- Positive clinical history with inhalant allergy to at least one of the allergen to be standardized.
- At least one positive prick test (mean wheal diameter greater or equal than 3mm) .
- Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml
- Age: 18-60 years
Key exclusion criteria (5 listed)
- Immunotherapy in the 2 years prior to the study against either the allergen to be tested or an allergen which is cross-reactive. (it is not applicable to no atopic patients)
- Any drug which may interfere with the cutaneous test or with its result.
- Any medical condition that from investigator's point of view the skin prick test cannot be done .
- Women who are pregnant or breast-feeding or are child-bearing age and who have not demonstrated that they have been surgically sterilized or have other means of not bearing children.
- 4.Subjects who have participated in another clinical trial within 3 months prior to this study.
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 |
|---|---|---|
| Skin Prick TestSkin prick test of 4 concentrations of each allergenic source, 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. Assessment of the wheal size after 15 minutes. | Biological | Allergic Subjects |
| Skin Prick Test - Atopic SubjectsSkin prick test of 4 concentrations of each allergenic source,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. Assessment of the wheal size after 15 minutes. | Biological | Atopic Subjects |
| Skin Prick Test - No Atopic SubjectsSkin prick test of 4 concentrations of each allergenic source, 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 subjects in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes. | Biological | No Atopic Subjects |
Primary outcome
Wheal size area
Time frame: 15 minutes after skin prick test
The primary efficacy variable will be the wheal size area at the site of the puncture of the immediate phase reaction in mm2.
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.
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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.
Arantza Vega, MD principal investigator
University of Guadalajara
Pilar Alba, MD principal investigator
Hospital de Manises
José Manuel Zubeldia, MD principal investigator
Hospital Universitario Gregorio Marañón
7 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 Skin Prick Test, Skin Prick Test - Atopic Subjects and Skin Prick Test - No Atopic Subjects in people with Sensitization to Allergens, run by Roxall Medicina España S.A at 7 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 20 inclusion and 5 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 7 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?
Wheal size area (time frame: 15 minutes after skin prick test). 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.