AllergyPhase 2NCT01147159
Biological Standardization of Allergen Extracts of Pollens of Betula Pendula, Phleum Pratense and Mite Extract of Dermatophagoides Pteronyssinus
A Phase 2 study testing Extracts of allergens in people with Allergy, run by Roxall Medicina España S.A at 1 site in Switzerland.
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 years
- Conditions the study is for
- Allergy
- What is being tested?
- Extracts of allergens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2010to Apr 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 = 3mm) when tested with already standardized extracts of the allergens under investigation.
- Positive prick test (wheal diameter =3 mm) to Histamine 10 mg/ml
- Age: 18-60 years
- Written informed consent
Who cannot join
- Diseases or medications, influencing the skin tests or that contradict the correct conduct and evaluation of the study.
- Pregnancy, skin irritations, drug and alcohol abuse and participation in another clinical trial within the last 30 days
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Zentrum für klinische Forschung Clinical Trials Center, University Hospital and University Zurich
Zurich, CH-8091
About this study
Official title: Biological Standardization of Allergen Extracts of Pollens of Betula Pendula, Phleum Pratense and Mite Extract of Dermatophagoides Pteronyssinus in Patients With Rhinoconjunctivitis With/ Without Asthma Sensitized to Betula Pendula, Dermatophagoides Pteronyssinus and Phleum Pratense An Open-label, Single-center Study
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 10,000 Diagnostic Biological Units (DBU) per ml (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 clinically allergic and cutaneously reactive to the allergen concerned.
The present study aims to standardize the allergen extracts of Betula pendula, Phleum pratense and Dermatophagoides pteronyssinus by using this method.
- Trial with medicinal product
- Conditions
- Allergy
- Being tested
- Extracts of allergens
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracts of allergensOther
Skin prick test of extracts of allergens in 4 tenfold dilutions. Assessment wheal size after 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Skin Prick Test | Other | Not described Receives: Other: Extracts of allergens |
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 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 posted22 Jun 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies 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
- Model description
- Skin prick test of extracts of allergens in 4 tenfold dilutions.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxall Medicina España S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147159
- Sponsor's protocol ID
- BIA-STD-001
- Status last verified
- Apr 2017
- First submitted
- 25 May 2010
- Last updated
- 2 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Standardization of Allergen Extracts of Pollens of Betula Pendula, Phleum Pratense and Mite Extract of Dermatophagoides Pteronyssinus in Patients With Rhinoconjunctivitis With/ Without Asthma Sensitized to Betula Pendula, Dermatophagoides Pteronyssinus and Phleum Pratense An Open-label, Single-center Study
- ClinicalTrials.gov ID
- NCT01147159
- Acronym / sponsor ID
- BIA-STD-001
- Conditions
- Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Roxall Medicina España S.AIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Zürich
- Study start
- Dec 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 22 Jun 2010 (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 10,000 Diagnostic Biological Units (DBU) per ml (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 clinically allergic and cutaneously reactive to the allergen concerned.
The present study aims to standardize the allergen extracts of Betula pendula, Phleum pratense and Dermatophagoides pteronyssinus by using this method.
- Trial with medicinal product
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Skin prick test of extracts of allergens in 4 tenfold dilutions.
| Arm | Type | Receives |
|---|---|---|
| Skin Prick Test | Other | Other: Extracts of allergens |
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 with inhalant allergy to at least one of the allergen to be standardized.
- At least one positive prick test (mean wheal diameter = 3mm) when tested with already standardized extracts of the allergens under investigation.
- Positive prick test (wheal diameter =3 mm) to Histamine 10 mg/ml
- Age: 18-60 years
- Written informed consent
Key exclusion criteria (2 listed)
- Diseases or medications, influencing the skin tests or that contradict the correct conduct and evaluation of the study.
- Pregnancy, skin irritations, drug and alcohol abuse and participation in another clinical trial within the last 30 days
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 |
|---|---|---|
| Extracts of allergensSkin prick test of extracts of allergens in 4 tenfold dilutions. Assessment wheal size after 15 minutes | Other | Skin Prick Test |
Primary outcome
Wheal size area
Time frame: 15 minutes after skin prick test
The primary efficacy variable will be the wheal size area 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 2 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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Extracts of allergens in people with Allergy, run by Roxall Medicina España S.A at 1 site in Switzerland.
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 2 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 2 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 1 site in Switzerland. 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 2 May 2017.