Allergy to Ambrosia elatior (ragweed) MedDRA version: 14.1 Level: LLT Classification code 10036664 Term: Prick test System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: Ambrosia elatior prick test 0.01
Pharmaceutical Form: Solution for provocation test
Other descriptive name: Ambrosia elatior allergen extract
Concentration unit: mg/ml milligram(s)/milli
Sponsors
LETI Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: > Subject has provided written informed consent including data protection declaration, appropriately signed and dated by the subject > Subject can be male or female of any race and ethnic group > Women of child-bearing potential must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of ß-HCG) within 3 days prior to the Titrated Skin Prick Test, being the result available before any study procedure is performed. Woman of child-bearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (Defined as: age > 45 years plus 12 months of spontaneous amenorrhea or age > 45 years plus 6 months of spontaneous amenorrhea with serum FSH levels >40 mIE/mL). > Age > 18 years and A documented positive case history of allergy related to ragweed (Ambrosia elatior) > A positive SPT for Ambrosia elatior (ragweed) obtained within one year from the study procedure (tSPT).with a standardized product (ALYOSTAL Prick 100 IR Hohe Ambrosie, Stallergenes): mean wheal diameter = 3 mm. > A mean wheal diameter = 7 mm as reaction to a SPT with histamine dihydrochloride 10 mg/ml (positive control). > A positive test for specific IgE (RAST > 2) to Ambrosia elatior (ragweed) obtained within one year from the study procedure (tSPT). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: > Subject is on treatment with ß-blockers. > Subject is on treatment with tricyclic or tetracyclic antidepressants. > Any disease requiring therapeutic use of systemic corticosteroids either as chronic treatment or in repeated, intermittent treatment. > Diseases of the immune system, both autoimmune and immune deficiencies. > Treatment with substances interfering with the immune system prior and during the study (for wash-out periods please refer to Section 9.1 and Appendix 1). > Use of drugs that may interfere with the skin responses prior and during the study (please refer to Section 9.1 and Appendix 1). > Severe uncontrolled diseases that could increase the risks concerning the subject’s safety, including but not limited to: cardiovascular insufficiency, any severe or unstable respiratory diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders. > Any disease which prohibits the use of adrenaline (hyperthyroidism, arterial hypertension, severe peripheral vasculopathy, severe coronary insufficiency, cardiopathy, etc.) > Dermographism, atopic dermatitis (local at the test site), urticaria. > Pregnant or breastfeeding women > Lack of cooperation which may interfere with the study > Subjects with severe psychiatric, psychological or neurological disorders. > Participation in any other clinical trial within 30 days prior to the subject inclusion in this clinical trial > Specific immunotherapy with ragweed allergenic extract within the last 5 years. > Previous participation in this study > Alcohol, drug or medication abuse within the past year. > Use of any other prohibited drug or non-drug therapy detailed in Section 9. > Subjects who are employees at the investigational site or dependent and/or first degree relative or partner of the investigator. > Subjects who are jurisdictionally or governmentally institutionalized > Subject who plan to donate germ cells, blood, organs or bone marrow within 1 month after the end of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify the concentration of a native Ambrosia elatior extract inducing the same wheal size as provoked by 10mg/ml Histamine hydrochloride;Secondary Objective: Documentation of Adverse Drug Reactions, specific IgE against Amb a1;Primary end point(s): The primary endpoint is the wheal size area (mm2) of the immediate phase reaction provoked by 0.01, 0.1, 1,0, 10 and 15mg/ml freeze dried allergen extract of Ambrosia elatior. The concentration of Ambrosia elatior allergen extract provoking a wheal size of the same area as caused by Histamine Dihydrochloride 10 mg/ml will be determined and defined as 10 HEP/ml.;Timepoint(s) of evaluation of this end point: 15 minutes after application of the IMP | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint is the assessment of all Adverse Events (AE) and their relation to IMP to define Adverse Drug Reactions.;Timepoint(s) of evaluation of this end point: after application of the IMP (up to 48 hrs) | — |
Countries
Germany
Contacts
Public ContactMedical Department
LETI Pharma GmbH
Outcome results
None listed