Application of different concentrations of ragwood-allergen-solution (Ambrosia elatior allergen extract) as Prick-Test to define a standard with certain specifications

• Conditions: Allergy to Ambrosia elatior (ragweed); MedDRA version: 14.1Level: LLTClassification code 10036664Term: Prick testSystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2011-002096-42-DE
• Lead Sponsor: ETI Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-07
• Last Update Posted: 31 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 < 70 years at screening
> 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

> 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified