Sensitisation to one or more allergens of 6-grass pollen mixture (Holcus lanatus, Dactylis glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca elatior), house dust mite (Dermatophagoides pteronyssinus), birch pollen and mugwort pollen. MedDRA version: 8.1 Level: LLT Classification code 10036664 Term: Prick test
Conditions
Interventions
Trade Name: Prick Test Solution 6-Grass Pollen
Product Name: Skin Prick Test Solution 6-Grass Pollen
Pharmaceutical Form: Cutaneous solution
Trade Name: Prick Test Solution Birch Pollen
Product Name:
Sponsors
Allergopharma Joachim Ganzer KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed informed consent document Male and female outpatients, 18-60 years Patients with an anamnesis referring to suspicion of an IgE-mediated allergy (type I acc. to COOMBS and GELL) against at least one of the investigational allergens For at least one of the investigational allergens with an existing anamnesis there also has to be a positive skin prick test in the medical history. The skin prick test must not be older than 12 month. For female patients: effective contraception and negative pregnancy test result Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous course of immunotherapy against any of the investigational allergens Actual injections in the course of a current specific immunotherapy Clinically relevant rhinitis/rhinoconjunctival or respiratory symptoms related to other reasons that have not been clearly identified Moderate to severe bronchial asthma (GINA grade III to IV) PEF<80% Unnatural change of the skin as well as urticaria, atopic dermatitis or tattoos in the test area Actual use of steroids on the test area Long-term therapy with steroids, antihistamines, benzodiazepines, antidepressants or other psychoactive drugs Consumption of antiallergic medication 7 days or longer (according to the half-life of medication) before the testing or use of oral steroids 6 weeks before the testing Vasomotor, drug-induced or other kinds of non-allergic rhinoconjunctivitis Febrile infections or inflammation of the respiratory tract at the time of inclusion (bronchitis etc.) Severe acute or chronic diseases, severe inflammatory diseases Other severe generalised diseases (liver, kidneys, metabolic diseases (diabetes)) Autoimmune diseases, immune-defects including immuno-suppression, immune-complex-induced immunopathies Multiple sclerosis, active tuberculosis Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse) Contra-indications for application of adrenaline: Severe acute or chronic symptomatic coronary heart disease Severe arterial hypertension Treatment with ß-blockers or ACE-inhibitors Pregnancy and lactation period Female patients seeking to become pregnant Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days Low compliance or inability to understand instructions/study documents Patients being in any relationship of dependence with the Sponsor and/or with the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Main Objective: Allergopharma skin prick tests for the investigational allergens are currently available in Germany and other European countries on the base of national marketing authorisations. This clinical trial will be carried out according to the Committee for Proprietary Medicinal Products (CPMP) in the “Points to Consider on the Evaluation of Diagnostic Agents” and the latest ICH-GCP requirements in order to demonstrate tolerability and to assess diagnostic sensitivity and specificity in a representative number of patients. The results are intended for submission to additional international regulatory authorities by Mutual Recognition Procedure. ;Primary end point(s): The evaluation of the optimal trade-off between sensitivity and specificity will be done by the method of the Receiver Operating Characteristic (ROC) analysis with three different test systems / methods used as “absolute standard”: the ImmunoCAPTM Fluoro enzyme immuno essay, the anamnesis and a skin prick test in the medical history. | — |
Countries
Germany
Outcome results
None listed