- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01675349
Biological Standardization of Chenopodium Album Allergen Extract
Biological Standardization of Chenopodium Album Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units
Study Overview
Status
Conditions
Intervention / Treatment
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 Chenopodium album 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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Alicante, Spain
- Hospital General de Elche
-
Córdoba, Spain, 14006
- Centro Médico Adeslas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 > and =18 years and < and =60 years at the study inclusion day.
- Positive skin prick test with a standardized commercially available preparation of chenopodium album allergen extract.
- A positive test for specific IgE to chenopodium album (CAP-RAST major or equal to 2).
- Allergic symptoms during the pollen season of Chenopodium album.
- Medical history positive allergy inhalation (rhinitis and /or rhinoconjunctivitis and/or asthma) from Chenopodium album.
Exclusion Criteria:
- Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested.
- Use of drugs that may interfere with the skin reactions (e.g., antihistamines).
Treatment with any of the following medications: tricyclic or tetracyclic
o IMAOs antidepressants,b-blockers or chronic use of corticosteroids or oral or use of corticoids both via oral or parenteral, in repeated patterns and intermittent (> 10 mg/día de prednisone or equivalent).
- Women who are pregnant or period of breastfeeding and women with a pregnancy test positive during the visit 2, prior to the prick test.
- 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.
- Urticaria affecting the skin area at the test site at either study visit.
- Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.
- Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases, endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases.
- Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial.
- Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension, ..)
- Severe psychiatric, psychological or neurological disorders
- Abuse of alcohol, drugs or medicines in the previous year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chenopodium album allergen extract
Four concentrations of Chenopodium album 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.
This test will be referred to as the Titrated Skin Prick test.
|
This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines. Four concentrations of Chenopodium album 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. This test will be referred to as the Titrated Skin Prick test.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
Time Frame: 15-20 min after application
|
15-20 min after application
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Lena Erbiti, Laboratorios LETI, S.L.Unipersonal
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 6062 -PR-PRI-195
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 to Chenopodium Album
-
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
-
Abionic SAJohns Hopkins University; NAMSAWithdrawnAllergy | Allergic Asthma | Allergy to Cats | Allergy to House Dust | Allergy to Dog Dander | Allergy CockroachUnited States
-
Sayantani B. SindherNational Institute of Allergy and Infectious Diseases (NIAID)TerminatedAllergy;Food | Allergy to Shrimp | Allergy to Cashew Nut (Disorder)United States
-
University Hospital, RouenCompletedAllergy to Egg | Allergy to PeanutFrance
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of ZurichImVision AGCompletedAllergy to CatsSwitzerland
-
Mahidol UniversityActive, not recruitingImmunotherapy | Allergy to ShrimpThailand
-
Laboratorios Leti, S.L.Completed
-
George StavroulakisOdense University Hospital; Medical University of Lodz; National and Kapodistrian... and other collaboratorsCompletedFood Allergy to FishDenmark, Greece, Iceland, Netherlands, Poland, Spain
Clinical Trials on Prick test Chenopodium album allergen extract
-
Laboratorios Leti, S.L.CompletedAllergy to Platanus AcerifoliaSpain
-
Laboratorios Leti, S.L.CompletedAllergic Rhinitis | Allergic Asthma | Allergy Dermatophagoides PteronyssinusSpain
-
National Institute of Allergy and Infectious Diseases...Consortium of Food Allergy ResearchTerminated
-
Imperial College LondonNovartis PharmaceuticalsCompleted
-
Prescott WoodruffNational Institute of Allergy and Infectious Diseases (NIAID)Completed