food allergy food allergy
Conditions
Interventions
The test drug with the allocation number (a total of 1.0 mL of a solution of 0.3 mL of venetrin inhalation solution or placebo (saline) and a mixture of 0.7 mL of saline) is inhaled using a nebulizer
Sponsors
Takaoka Yuri
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed with or suspected of having egg allergy who are undergoing an oral food challenge (OFC) with egg to confirm the tolerable dose or for diagnostic purposes Patients aged 5 years or older and under 18 years at the time of consent Patients from whom written informed consent for participation in the study can be obtained, either from the subject themselves (if aged 16 or 17) or from a legally authorized representative
Exclusion criteria
Exclusion criteria: Individuals who are judged to have difficulty appropriately reporting abdominal pain using a face scale due to underlying diseases or other conditions. Individuals who are currently participating in another interventional study for food allergy. Individuals who have previously been enrolled in this study due to abdominal pain and have received an assigned treatment. Individuals who used a short-acting beta2-agonist on the day before or prior to the start of the OFC (use of ICS/LABA is permitted), or who used systemic steroids from 14 days before the OFC through the day of the OFC. Individuals with hypersensitivity to beta2-agonists. Individuals with a history of heart disease or arrhythmia. Individuals with a history of adrenaline (epinephrine) administration during an OFC using the same challenge food and the same challenge dose as the planned OFC. Individuals who are deemed inappropriate as study subjects by the principal investigator or sub-investigators for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who had an improvement in the face scale of abdominal pain under 2 within 20 minutes after salbutamol inhalation | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of cases in which abdominal pain due to food allergy disappeared within 20 minutes after inhalation of the investigational drug Time to resolution of abdominal pain after inhalation of the investigational drug Proportion of cases in which adrenaline was used after inhalation of the investigational drug Heart rate before and after inhalation of the investigational drug (up to 40 minutes) | — |
Contacts
Public ContactYuri Takaoka
Osaka Habikino Medical Center
Outcome results
None listed