Open, comparative, randomized study on the efficacy, safety and bioavailability of highly concentrated inhaled epinephrine (4 mg L-epinephrine / ml, Infectokrupp® Inhal) versus epinephrine autoinjector application (Fastjekt® Junior) in infants with acute anaphylactic reaction during a food provocatio

Phase 1

• Conditions: Food allergy; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-000097-19-DE
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-12
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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

- 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

Study & Design

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