- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01147159
Biological Standardization of Allergen Extracts of Pollens of Betula Pendula, Phleum Pratense and Mite Extract of Dermatophagoides Pteronyssinus
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Zurich, Switzerland, CH-8091
- Zentrum für klinische Forschung Clinical Trials Center, University Hospital and University Zurich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Skin Prick Test
|
Skin prick test of extracts of allergens in 4 tenfold dilutions.
Assessment wheal size after 15 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
15 minutes after skin prick test
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BIA-STD-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Allergy
-
University of RochesterNational Institute of Allergy and Infectious Diseases (NIAID)Not yet recruitingEgg Allergy | Food Allergy Peanut | Food Allergy in Infants | Allergy and Immunology | Peanut and Nut AllergyUnited States
-
Hong Kong Sanatorium & HospitalChinese University of Hong KongTerminatedAllergy to Fish | Allergy to Shrimp | Allergy to CrabHong Kong
-
Abionic SAJohns Hopkins University; NAMSAWithdrawnAllergy | Allergic Asthma | Allergy to Cats | Allergy to House Dust | Allergy Cockroach | Allergy to Dog Dander (Finding) | Allergy MoldUnited States
-
King's College LondonGuy's and St Thomas' NHS Foundation TrustUnknownEgg Allergy | Food Allergy | Food Allergy in Children | Milk Allergy | Food Allergy in Infants | Nut Allergy | Food Allergen SensitisationUnited Kingdom
-
Peking University Third HospitalCancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing... and other collaboratorsRecruitingCow Milk Allergy | Food Allergy in ChildrenChina
-
King's College LondonKing's College Hospital NHS Trust; University College London Hospitals; Cambridge... and other collaboratorsRecruitingEgg Allergy | Food Allergy | Food Allergy in Children | Milk Allergy | Food Allergy in Infants | Nut Allergy | Food Allergen SensitisationUnited Kingdom
-
Chinese University of Hong KongRecruiting
-
Martini Hospital GroningenRecruitingCow Milk Allergy | Food AllergyNetherlands
-
University GhentActive, not recruitingCow Milk Allergy | Food AllergyBelgium
-
Sayantani B. SindherNational Institute of Allergy and Infectious Diseases (NIAID)TerminatedAllergy;Food | Allergy to Shrimp | Allergy to Cashew Nut (Disorder)United States
Clinical Trials on Extracts of allergens
-
Brigham and Women's HospitalCompleted
-
University of Missouri-ColumbiaTerminated
-
Bayside HealthNational Health and Medical Research Council, Australia; The Alfred; Australian...CompletedFood Allergy | AnaphylaxisAustralia
-
University of North Carolina, Chapel HillMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsEnrolling by invitationEosinophilic Esophagitis | EoEUnited States
-
Christina WestNutricia, Inc.; The Västerbotten county council; State Government founding for... and other collaboratorsCompleted
-
Fundación Pública Andaluza para la gestión de la...RecruitingStroke | Ischemic Stroke | Brain Ischemia | Neurovascular InjurySpain
-
St. Petersburg Research Institute of Vaccines and...CompletedTolerability and Reactogenicity Trial of the Recombinant Tuberculosis Allergen in Healthy VolunteersTuberculosis | Skin TestsRussian Federation
-
Biosearch S.A.CompletedCardiovascular DiseaseSpain
-
Biosearch S.A.Completed
-
University of ZurichTerminated