Anaphylactic Symptoms Induced by An Oral Food Challenge Test
Conditions
Interventions
Subjects 15 to <30kg body weight will receive a single 1.0mg/100microL Intranasal dose of ARS-1 in a nare.
Subjects 30 kg or greater body weight will receive a single 2.0mg/100microL Intranasal dose o
Sponsors
Kenya Morita
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Between the ages of 4 and 55 years at IC 2. Has body weight 15 kg or higher before OFC test at Day1 3. Is scheduled for an inpatient oral food challenge test. 4. Must have an oral food allergy that elicited symptoms of grade 2 or higher gastrointestinal, respiratory, or circulatory symptoms according to the Severity Classification of Organ Symptoms Induced by Anaphylaxis in the Anaphylaxis Guidelines of the Japanese Society of Allergology.
Exclusion criteria
Exclusion criteria: 1. Has prior nasal fractures, severe nasal injuries, history of nasal disorders, any nasal conditions that could interfere with nasal spray administration, abuse of nasal decongestants, or sleep apnea. 2. Has used nasal drugs within 14 days from Day1. 3. Has mucosal inflammatory disorders (e.g., pemphigus or Sjogren's syndrome or fungal sinusitis). 4. Known hypersensitivity to any compound in sympathomimetics or any compounds contained in investigational drugs (adrenaline, n-dodecyl-beta-D-maltoside, sodium edetate hydrate, benzalkonium chloride, sodium pyrosulfite) or other closely related compound.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in main symptoms at 15 minutes after an administration of ARS-1 or at the final evaluation before alternative treatment. | — |
Contacts
Public ContactMorita Kenya
MEDISCIENCE PLANNING INC.
Outcome results
None listed