Clinical trials: Anaphylactic Reaction
Peanut Allergy, Peanut Hypersensitivity
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
The overall aims of this study are to demonstrate that treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing clinical reactivity to peanut protein in children and adolescents with…
- Conditions
- Peanut Allergy, Peanut Hypersensitivity, Peanut-Induced Anaphylaxis, Immune System Diseases
- Trial name
- NCT05621317
- Testing
- PVX-108
- Where
- 14 sites in United States, Australia
- Volunteers
- 90 people
- Sponsor
- Aravax Pty Ltd
Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
The goal of this observational study is to evaluate the safety of sulbactam-durlobactam, as well as the risk of hypersensitivity reactions (including anaphylaxis) in participants with Acinetobacter baumannii-calcoaceticus complex…
- Trial name
- NCT06746883
- Testing
- Non-interventional
- Where
- 12 sites in United States
- Volunteers
- 100 people
- Sponsor
- Innoviva Specialty Therapeutics
Anaphylaxis, Anaphylactic Reaction
Comparative Bioavailability of Intranasal Epinephrine
A Study to Compare the Bioavailability of Epinephrine following a Single Nasal Dose of FMXIN002 Microspheres Powder 3.6 mg, and 4mg with EpiPen 0.3mg Intramuscular Injection in Healthy Adults
- Trial name
- NCT06205134
- Testing
- A: Epinephrine injection, B: FMXIN002 3.6mg, C: FMXIN002 4.0mg
- Where
- Israel
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Nasus Pharma
Contrast Medium
Study on the Risk of Allergy-like Reactions After Intra-arterial or Intra-venous Injection of the Marketed X-ray Contrast Medium Iopromid
Iopromide (trade name is Ultravist) is on the market for more than 30 years and has been used more than 250 million times as X-ray contrast medium for patients.
- Trial name
- UVIA (NCT03622801)
- Testing
- Iopromide (Ultravist, BAY86-4877)
- Where
- Germany
- Volunteers
- 133,331 people
- Sponsor
- Bayer
Anaphylaxis, Allergy
Comparative PK/PD of FMXIN002 and EpiPen, in Healthy Adults With Allergic Rhinitis
The study will evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) responses of FMXIN002, an intranasal epinephrine powder, compared with the EpiPen® intramuscular autoinjector, after single and double doses, in healthy…
- Trial name
- NCT07228325
- Testing
- FMXIN002 single dose, Epinephrine autoinjector single dose, FMXIN002 single dose + NAC
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Nasus Pharma
Anaphylaxis
Satisfaction of Patient With Anaphylaxis in the Use of a Medical Device
Through several questionaries the investigators will measure the satisfaction of patients diagnosed with anaphylaxis in the use of a medical device for the adrenaline autoinjector, a smart case for an epinephrine autoinjector…
- Trial name
- NCT02854969
- Testing
- Device: Anapphylaxis
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Adan Medical Innovation, SL
Hypersensitivity Reactions
Post-market Safety Study of LUMISIGHT
This study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with…
- Trial name
- NCT07572162
- Where
- 2 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Lumicell, Inc.
Allergic Asthma
Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing
This study will establish a clinical data and serum repository of anaphylaxis cases associated with Xolair administration and control patients who have received Xolair without associated anaphylaxis.
- Trial name
- X-PAND (NCT00813748)
- Testing
- Xolair
- Where
- 7 sites in United States
- Volunteers
- 118 people
- Sponsor
- Genentech, Inc.
Anaphylactic Reaction
Study of Inhaled DMC-IH1 and Intramuscular (EpiPen®) Epinephrine in Healthy Male and Female Participants.
This is a phase 1, randomised, double blind placebo controlled 2-part study to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of inhaled DMC-IH1 (epinephrine) and relative bioavailability and carryover effects…
- Trial name
- NCT06013150
- Testing
- Epinephrine
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- De Motu Cordis
Pharmacokinetics, Epinephrine
Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals
To 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.
- Conditions
- Pharmacokinetics, Epinephrine, Albuterol, Asthma
- Trial name
- NCT04207840
- Testing
- Epinephrine (0.125 mg/inhalation), Epinephrine Injection Auto-Injector (0.3mg/0.3mL), Albuterol Sulfate (0.09 mg/inhalation)
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Amphastar Pharmaceuticals, Inc.
Anaphylactic Reaction
Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults
This is a study to determine the relative bioavailability of inhaled epinephrine compared with 0.3mg epinephrine administered IM in healthy male and female participants.
- Trial name
- NCT05152901
- Testing
- EpiPen ®., Epinephrine (0.3mg) inhaled, Epinephrine (1.3mg)
- Where
- Australia
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- De Motu Cordis
Epinephrine, Hypersensitivity, Immediate
Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
This Phase 2, open-label, single-arm study will evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of a single dose of epinephrine nasal spray (ENS) in children and adolescents 2 to 17 years of age with a…
- Conditions
- Epinephrine, Hypersensitivity, Immediate, Anaphylaxis
- Trial name
- NCT07891780
- Testing
- Epinephrine Nasal Spray, 2.5 mg, Epinephrine Nasal Spray, 5.25 mg
- Where
- 2 sites in United States
- Volunteers
- 44 people
- Sponsor
- Hikma Pharmaceuticals USA Inc.
Peanut-Induced Anaphylaxis, Peanut Allergy
UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies
This study will test a new investigational treatment called UKK-0018. UKK-0018 as an immunotherapeutic for the treatment of peanut allergies.
- Trial name
- UKK-0018 (NCT07349212)
- Testing
- UKK-0018
- Where
- 6 sites in Australia, New Zealand
- Volunteers
- 40 people
- Sponsor
- Ukko Inc
Hypersensitivity
Coreg and HSRs-Updated Analysis
A cluster of reports of hypersensitivity reactions among patients who switched from carvedilol (immediate release formulation, referred to hereafter as carvedilol) to carvedilol extended release was received during the initial…
- Trial name
- NCT01316952
- Testing
- Carvedilol immediate release only, Carvedilol extended release only, Long acting β-blockers
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Anaphylaxis
Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)
A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects
- Trial name
- NCT03282929
- Testing
- Part 1, Part 2 Group 1, Part 2 group 2
- Where
- Germany
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Bausch & Lomb Incorporated
Food Allergy, Anaphylaxis
PK/PD Study of IN-001 Sublingual Spray in Healthy Adults
This is an open-label, three-part study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine administered as a single dose of L-dipivefrin (IN-001) sublingual spray or drop in healthy adults.
- Conditions
- Food Allergy, Anaphylaxis, Food Hypersensitivity, Food Allergy Peanut
- Trial name
- NCT07210320
- Testing
- Epinephrine Auto-Injector 0.3 mg/0.3 mL, Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle, IN-001 9.06 mg Sublingual Spray
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Insignis Therapeutics, Inc.
Anaphylaxis Food
FMXIN002 in Patients at Risk of Anaphylaxis
Study Objective To evaluate the efficacy of FMXIN002, a powder-based intranasal epinephrine spray, for treating anaphylaxis. Study Design Hypothesis: FMXIN002 will terminate anaphylactic reactions as effectively-or more…
- Trial name
- NCT07045701
- Testing
- Epinephrine 4mg nasal powder spray, Adrenalin 0.5mg Injectable Product
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- Nasus Pharma
Food Hypersensitivity, Anaphylaxis
A Study About the Use of Omalizumab in the Treatment of Food Allergy and Anaphylaxis
This was a retrospective, multi-center observational study conducted across four allergy departments in Europe (Berlin, Leipzig, Barcelona, and Basel).
- Trial name
- NCT07027163
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Pompe Disease
Alglucosidase Alfa Pompe Safety Sub-Registry
To collect uniform and meaningful data on patients with Pompe disease who experience anaphylaxis, severe allergic reactions, and/or signals of severe cutaneous and/or systemic immune complex-mediated reactions following treatment…
- Trial name
- NCT01710813
- Testing
- alglucosidase alfa
- Where
- 18 sites in United States, Belgium and 4 more
- Volunteers
- 110 people
- Sponsor
- Genzyme, a Sanofi Company
SARS-CoV-2
Post-Marketing Safety Study in Japan of Shock and Anaphylaxis After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in Persons in at High Risk of Severe COVID-19
The goal of this study is to confirm the onset status of hypersensitivity reactions including shock and anaphylaxis observed after vaccination with this drug in persons with underlying diseases who are considered to have a high…
- Trial name
- NCT05894499
- Where
- Japan
- Volunteers
- 13,309 people
- Sponsor
- ModernaTX, Inc.