Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female...
AnaphylaxisA single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects
Evaluation of Medical Care and Patient's Knowledge About the Behavior to Take on Secondary Prevention...
AnaphylaxisAnaphylaxis is a hypersensitivity reaction systemic, generalized, severe, life-threatening that may result from exposure to a triggering factor. The prevalence of anaphylaxis is 0.05 to 2% in the general population. Most reactions appear within 30 minutes after contact with the triggering factor and last up to 6 hours. The main triggering factors are: 1/food, 2/hymenopteran bites, 3/drugs. The main treatment is the early administration of adrenaline by Intramuscular route on medical prescription or by AAI (adrenaline auto-injector) associated with the exclusion of the allergen. Adrenaline treatment should be administered as soon as possible, a failure or delay in the use of adrenaline is a risk factor for death. Anaphylaxis is a chronic disease and the patient must be informed from the first episode about the risk of recurrence and the risk of death he is exposed to. Patient education is essential for the complete removal of the triggering factor, recognition of anaphylaxis symptoms and use of AAI. The risk of recurrence is high given the difficulty to completely eliminate the favourable factor (mainly food causes and hymenopteran bites): 1/3 of deaths from food anaphylaxis occur at home, and the peak mortality rate is between 10 and 30 years old. The diagnosis of anaphylaxis can be difficult because the symptomatology can be so varied. It is under-diagnosed, which leads to a lack of medical care and therefore an under-prescription of AAI. Some American studies identifying emergency room visits for anaphylaxis find that in less than 30% of cases there is a prescription for AAI, in less than 40% of advices about triggering factor's eviction and in less than 20% a guidance to an allergology consultation. In France, the HAS published in 2013 a procedure to be followed after the treatment of a suspected anaphylaxis: the patient's management must be diagnostic, therapeutic and educational. It must be systematically based on three axes: the prescription of AAI with an explanation of its use, the provision of written information on the mechanism and symptoms of anaphylaxis, attitude to be followed in event of an anaphylactic reaction, and need for eviction if the allergen has been identified, guidance to an allergology consultation. Therapeutic education for anaphylactic patients is essential given the risk involved. In an American study, it was shown that only 60% of teens and young adults suffering from food allergies report having AAI systematically with them. Information and education is therefore essential for these patients.
Smartphone Apps for Pediatric Resuscitation
Status EpilepticusAnaphylaxisMedication errors are common in children. Characteristics of errors during critical situations in the Emergency Department are ill-defined and might be more frequent than previously thought. However, optimal strategies to eliminate the risk of prescribing errors remain unknown. Many smartphone apps have been suggested over the last years with some of them designed to calculate medication dosage for children. The impact of these apps to decrease dosage error has never been evaluated in resuscitation setting. The aim of the study is to evaluate whether the use of a smartphone application designed to calculate medication doses decreases prescribing errors among residents during pediatric simulated resuscitations. This will be a crossover-randomized trial using high fidelity simulation among 40 residents rotating in the pediatric emergency department.
A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy...
HypersensitivityAnaphylaxisThe purpose of this study is to assess the potential for hypersensitivity symptoms upon repeat exposure to sugammadex. Healthy participants will be randomized to one of three treatment arms: sugammadex 4 mg/kg, sugammadex 16 mg/kg or placebo. Participants will receive 3 single intravenous (IV) doses of their randomized treatment, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3. Participants will be confined at the study center from the day before each dose until completion of the 24-hour post dose assessments.
Bioavailability of Nasal Epinephrine
AnaphylaxisA Study to Compare the Bioavailability of Epinephrine following a Single Nasal Dose of FMXIN002 Microspheres Powder with Epinephrine 0.3 mg Intramuscular Injection in Adult Subjects with Seasonal Allergic Rhinitis with and without Nasal Allergen Challenge
Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine...
PharmacokineticsEpinephrine3 moreTo assess the drug exposure profile in systemic circulation of Primatene Mist by inhalation, versus Epinephrine by intramuscular injection, and ProAir HFA by inhalation in healthy adults.
Preventing Anaphylaxis With Acalabrutinib
Food AllergyFood Allergy PeanutFood allergy is a potentially life-threatening condition, and its prevalence continues to increase despite public health efforts. There are currently no known therapies that can reliably prevent food-induced anaphylaxis. This is an open-label study designed to determine the ability acalabrutinib to prevent signs and symptoms of anaphylaxis during an oral food challenge in food-allergic adults.
Mechanisms of Anaphylaxis
AnaphylaxisAllergy2 moreThe purpose of this study is to explore different mechanisms for anaphylaxis and find novel biomarkers for this hypersensitivity syndrome. The study participants are patients with anaphylaxis, patients with mild allergic reactions, and patients with febrile transfusion reactions. The investigators will also include a group of healthy controls.
Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study
Adverse Drug EventAdverse Drug Reaction2 moreThis registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.
Relevance of the Self-assessment of Skills for Self-administration of Adrenaline by Auto-injectors...
Severe Anaphylactic ReactionSelf-administration2 moreTo investigate the correlation between self-assessment by patients and an assessment by a health professional of the skills needed for self administration of adrenaline by auto-injectors. These skills include the identification of situations requiring the administration of adrenaline and the technical abilities to achieve it. Hypothesis: A self-assessment correlated with an external assessment would make it easier to adjust the frequency of therapeutic education sessions based on the patient's self-assessment alone.