HypersensitivityPhase 2NCT02474836
Determination of Biological Activity of Three Allergen Extracts
A Phase 2 study testing Skin Prick Test - Atopic subjects, Skin Prick Test - Non Atopic subjects and Skin Prick Test - Allergic subjects in people with Hypersensitivity, run by Roxall Medicina España S.A at 9 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 variability, 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
- Hypersensitivity
- What is being tested?
- Skin Prick Test - Atopic subjects, Skin Prick Test - Non Atopic subjects and Skin Prick Test - Allergic subjects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 9 sitesSpain
- Study dates
- Nov 2012to Sep 2013
- 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
- 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 28Show fewer
- Patients will be:preferably be monosensitized, or with clinically relevant sensitization , or with primary sensitization (maximum cutaneous reactivity) to the extracts under investigation.Patient who belongs to one of the following group:
- Monosensitized patient to one of the extracts under investigation
- Patient with clinically relevant sensitization to the extracts under investigation.
- Patient with primary sensitization to one of 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
- Wheal diameter greater or equal to 3 mm for:
- Any allergen, except pollen for the cases of Artemisia vulgaris and/or Platanus acerifolia pollen extracts.
- Any allergen, except mites for the case of Dermatophagoides farinae mite extract.
- In order to dismiss sensitization to other allergens, the wheal diameter should be less than 3 mm for:
- Any pollen (for the cases of Artemisia vulgaris and/or Platanus acerifolia pollen extracts)
- Any mites(for the case of Dermatophagoides farinae mite extract)
- 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 5 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.
- Subjects who have participated in another clinical trial within 3 months prior to this study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Al-lergo centre
Barcelona, Catalonia
Alergoclínica Virgen de Loreto
Córdoba, Andalusia
Hospital de Vinalopó
Elche, Alicante
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria
Clínica de asma y alergia
Madrid
Hospital General de Asturias
Oviedo, Principality of Asturias
Hospital Nuestra Señora De Candelaria
Santa Cruz de Tenerife
Hospital Arnau de Vilanova
Valencia
Hospital Clínico de Valencia
Valencia
About this study
Official title: Biological Standardization of Artemisia Vulgaris and/or Platanus Acerifolia Pollen Extract and Dermatophagoides Farinae Mite Extract 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 variability, 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 Artemisia vulgaris, Platanus acerifolia, Dermatophagoides farinae by using this method.
Read the detailed description
The present study aims to standardize the allergen extracts of Artemisa vulgaris, Platanus acerifolia and Dermatophagoides farinae by using this method. Standardized extracts will then be used for diagnostics and treatment of allergies as mentioned above.
- Conditions
- Hypersensitivity
- Being tested
- Skin Prick Test - Atopic subjects, Skin Prick Test - Non Atopic subjects, Skin Prick Test - Allergic subjects
- Keywords
- Allergy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 - Non 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.
Skin Prick Test - Allergic 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.
| Study group | Role | What they receive |
|---|---|---|
| Atopic subjects | Active comparator | Patients sensitized to other allergenic sources but the allergen extracts under investigation. Receives: Biological: Skin Prick Test - Atopic subjects |
| Non atopic subjects | Active comparator | Healthy volunteers Receives: Biological: Skin Prick Test - Non Atopic subjects |
| Allergic Subjects | Other | Not described Receives: Biological: Skin Prick Test - Allergic 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 posted18 Jun 2015 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxall Medicina España S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Araitz Landeta, Study chair, Roxall Medicina España S.A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474836
- Sponsor's protocol ID
- BIA-STD-003
- Other IDs
- 2012-000672-42
- Status last verified
- Apr 2017
- First submitted
- 24 Sep 2013
- 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 Artemisia Vulgaris and/or Platanus Acerifolia Pollen Extract and Dermatophagoides Farinae Mite Extract in Patients Sensitized to Them
- ClinicalTrials.gov ID
- NCT02474836
- Acronym / sponsor ID
- BIA-STD-003
- Conditions
- Hypersensitivity
- Keywords
- Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Roxall Medicina España S.AIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 18 Jun 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.
Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. Many factors such as the variability, 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 Artemisia vulgaris, Platanus acerifolia, Dermatophagoides farinae by using this method.
Detailed description
The present study aims to standardize the allergen extracts of Artemisa vulgaris, Platanus acerifolia and Dermatophagoides farinae by using this method. Standardized extracts will then be used for diagnostics and treatment of allergies as mentioned above.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atopic subjects | Active comparator | Biological: Skin Prick Test - Atopic subjectsPatients sensitized to other allergenic sources but the allergen extracts under investigation. |
| Non atopic subjects | Active comparator | Biological: Skin Prick Test - Non Atopic subjectsHealthy volunteers |
| Allergic Subjects | Other | Biological: Skin Prick Test - Allergic subjects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (28 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 5 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.
- 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 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 - Non 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 | Non atopic subjects |
| Skin Prick Test - Allergic 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 | Allergic 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.
Araitz Landeta study chair
Roxall Medicina España S.A
9 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 Skin Prick Test - Atopic subjects, Skin Prick Test - Non Atopic subjects and Skin Prick Test - Allergic subjects in people with Hypersensitivity, run by Roxall Medicina España S.A at 9 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 28 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 9 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 (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.