Open label, comparative, randomized trial of the efficacy, safety and bioavailability of highly concentrated inhalative epinephrine (4 mg L-Epinephrin/ml, Infectokrupp® Inhal) versus Epinephrin-Autoinjektor-Anwendung (Fastjekt® Junior) in infants with acute anaphylactic reaction in the course of a food challenge

Phase 2

Recruiting

• Conditions: T78.0; Anaphylactic shock due to adverse food reaction

• Registration Number: DRKS00011881
• Lead Sponsor: Charité Campus Virchow-Klinikum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

„Run-in-Phase:
• written informed consent of the parents to study participation
• age: 1 to 6 years of age
• Weight 7.5 to 30 kg
• planned inpatient admission in the context of a medically indicated oral food challenge

Treatment”-Phase:
• treatment-requiring anaphylactic reaction in the course of the oral food challenges, defined as:
(1.) at least two affected organ systems (skin, gastrointestinal tract, airways, and/or heart/circulation) with an anaphylaxis symptom score of at least 5 points or
(2.) peripheral or central airway obstruction or
(3.) drop in blood pressure (reduced systolic blood pressure 70 mm Hg plus 2 x age in years or drop in blood pressure: >30% drop of the systolic blood pressure)

Exclusion Criteria

- acute febrile infection
- known clinically relevant cardiac and circulatory disorders such as angina pectoris, obstructive cardiomyopathy, cardiac arrhythmias, coronary heart vessel diseases, diseases of the heart muscle, sclerotic vascular changes, cor pulmonale or atherosclerosis and clinically relevant hypertension
- known clinically relevant diabetes
- known hypercalcemia or hypokalemia
- known hyperthyroidism
- known phaeochromocytoma
- known severe renal impairment or
- bladder voiding disorders with residual urine formation
- known angle-closure glaucoma
- known other serious diseases which, according to the investigator’s judgement, hinder a participation
- known presence of other contraindications according to the medicinal product’s professional information of the investigetional products used (Infectokrupp® Inhal, Fastjekt® Junior), in particular the use of a contraindicated concomitant medication (see below)
- anamnestically known hypersensitivity reactions to components of one of the investigational products used, in particular sodium metabisulfite
- Prior participation in this study
- Participation in a clinical trial in the last 30 days
- inability of the parents to understand the study instructions; obvious unreliability or lack of cooperation of the parents
- use/intake of any of the following contraindicated concomitant medications or therapies:
- beta-blocker or alpha-receptor blocker
- digitalis glycosides, quinidines, halothane or cyclopropane
- levodopa, parasympatholytics (e.g. atropine)
- sympathomimetics, e.g. orciprenaline
- tri- and tetracyclic antidepressants
- monoamine oxidase inhibitors
- guanethidine, L-thyroxine
- oxytocin, ornipressin, carbazochrom
- insuline, antidiabetic drugs
- reserpine, mecamylamine
- certain antihistamines: diphenhydramine, chlorphenamine
- preparations which lead to potassium loss, e.g. potassium withdrawing diuretics, aminophylline or theophylline
- alcohol-containing preparations
- antihistamines or leukotriene receptor antagonists during the last 72 hours
- long-acting beta-2-mimetics or theophylline during the last 48 hours
- lack of willingness to store and transfer pseudonymized disease data within the limits of the clinical trial
- Accommodation in an institution by judicial or administrative order
- Patients and parents who are dependent on the investigator, the sponsor or the investigational site

Study & Design

• Study Type: interventional
• Study Design: Not specified