Food allergy
Conditions
Interventions
Trade Name: Infectokrupp® Inhal
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: epinephrine
CAS Number: 51-43-4
Other descriptive name: L-EPINEPHRINE HYDROGEN TARTRATE
Concentratio
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (Inclusion criteria) "run-in" phase: • Written consent of the parents in the study participation • Age: 1 to 6 years of age • Weight 7,5 to 30kg • Planned inpatient admission under a medically indicated oral food challenge (Inclusion criteria) "Treatment" phase: • anaphylactic reaction during the oral food challenges, defined by: (1) at least two affected organ systems (skin, gastrointestinal tract, respiratory tract, and / or heart / circulatory system) with an anaphylaxis symptom score of at least 5 points or (2) peripheral or central airway obstruction or o (3) drop of blood pressure (reduced systolic blood pressure 70 mm Hg plus 2 x age in years or drop of blood pressure:> 30% drop in systolic blood pressure value) Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Acute feverish infection - Known clinically significant cardiovascular disease such as angina pectoris, obstructive cardiomyopathy, arrhythmia, diseases of the coronary arteries, the heart muscle, sclerotic vascular changes, cor-pulmonale or atherosclerosis and clinically relevant hypertension - known clinically relevant diabetes - Known hypercalcemia or hypokalemia - Known hyperthyroidism - Familiar pheochromocytoma - Known severe renal dysfunction or bladder dysfunction with urinary retention - familiar narrow-angle glaucoma - Known other serious diseases which not allows a participation in the clinical trial in the opinion of the investigator - known presence of other contraindication according to SmPC(s) of the investigational medicinal product used (Infectokrupp® Inhal, Fastjekt® Junior), in particular if a contraindicated concomitant medication is used (see below) - A history of hypersensitivity reactions to ingredients of the IMP used, in particular sodium metabisulphite - Preceding participate in this study - Participation in a clinical trial during the last 30 days - inability of the parents to understand the study instructions; obvious unreliability or lack of cooperation of the parents - application / taking one of the following contraindicated concomitant medications or therapies: - beta blockers or alpha-blockers - digitalis, Chinidine, halothane or cyclopropane - levodopa, parasympatholytics (e.g. atropine) - sympathomimetic, e.g. orciprenaline - tri- and tetracyclic antidepressants - Monoamine oxidase inhibitors - guanethidine, L-thyroxine - oxytocin, ornipressin, carbazochrome - insulin, antidiabetics - reserpine, mecamylamine - Certain antihistamines: diphenhydramine, chlorpheniramine - pharmaceuticals which causes potassium loss: e.g. diuretics which reduces potassium: aminophylline or theophylline - pharmaceutical preparations containing alcohol - antihistamines or leukotriene receptor antagonist during the last 72 hours - Long-acting beta-2-agonists, or theophylline during the past 48 hours - unwilling to consent to saving and propagation of pseudonymised medical data for study reasons - Subjects who are legally detained in an official institution - Subjects and their parents who are in a dependent relationship with the Investigator or the Sponsor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Mean change of anaphylaxis symptom scores (ASC, considered weighted symptoms of the organ systems (CASC) and if necessary use of an additional medicinal anaphylaxis therapy, DASC) evaluated from baseline to endpoint after 20 minutes (for the FA (Full-Analysis-) population) ;Secondary Objective: • epinephrine plasma levels 10 minutes after the start of study medication application and changes to baseline levels determination at t1a • ASC and change from baseline (T1b) to all acquisition times (5, 10, 15, 20, 25, 30, 40, 50, 60 min.) • ASC single core values, sum of clinical score values (CASC), sum of additional anaphylaxis therapy score values (DASC) and change from baseline (T1b) to all detection times • Application of an additional drug therapy for the treatment of anaphylactic reactions • AEs, SAEs and side effects ;Primary end point(s): Primary endpoint Mean change of anaphylaxis symptom scores (ASC, considered weighted symptoms of the organ systems (CASC) and any necessary use of an additional medicinal anaphylaxis therapy, DASC) evaluated from baseline to endpoint after 20 minutes (for the FA (Full-Analysis-) population). ;Timepoint(s) of evaluation of this end point: after 20 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • epinephrine plasma levels 10 minutes after the application of the IMP and changes to baseline levels determination in t1a • ASC and change from baseline (T1b) to all detection times (5, 10, 15, 20, 25, 30, 40, 50, 60 min.) • ASC single core values sum of clinical score values (CASC), sum of additional anaphylaxis therapy score values (DASC) and change from baseline (T1b) to all detection times • Application of an additional drug therapy for the treatment of anaphylactic reactions • AEs, SAEs and side effects ;Timepoint(s) of evaluation of this end point: • epinephrine plasma levels 10 minutes after the application of the IMP and changes to baseline levels determination in t1a • ASC and change from baseline (T1b) to all detection times (5, 10, 15, 20, 25, 30, 40, 50, 60 min.) • ASC single core values sum of clinical score values (CASC), sum of additional anaphylaxis therapy score values (DASC) and change from baseline (T1b) to all detection times • Application of an additional drug therapy for the treatment of anaphylactic reactions • AEs, SAEs and side effects | — |
Countries
Germany
Contacts
Public ContactProf. Dr. med. Kirsten Beyer
Klinik für Pädiatrie m. S. Pneumologie und Immunologie
Outcome results
None listed