JRCT ID: jRCTs051250223
Registered date:10/02/2026
Effect of bronchodilator on abdominal pain
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | food allergy |
| Date of first enrollment | 10/02/2026 |
| Target sample size | 40 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | 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 when gastrointestinal symptoms in the food oral challenge test is observed. |
Outcome(s)
| Primary Outcome | Proportion of patients who had an improvement in the face scale of abdominal pain under 2 within 20 minutes after salbutamol inhalation |
|---|---|
| Secondary Outcome | 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) |
Key inclusion & exclusion criteria
| Age minimum | >= 5age old |
|---|---|
| Age maximum | < 18age old |
| Gender | Both |
| Include 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 |
| Exclude 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. |
Related Information
| Primary Sponsor | Takaoka Yuri |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Yuri Takaoka |
| Address | 3-7-1, Habikino, Habikino city, Osaka Osaka Japan 583-8588 |
| Telephone | +81-72-957-2121 |
| zvb11075@nifty.com | |
| Affiliation | Osaka Habikino Medical Center |
| Scientific contact | |
| Name | Yuri Takaoka |
| Address | 3-7-1, Habikino, Habikino city, Osaka Osaka Japan 583-8588 |
| Telephone | +81-72-957-2121 |
| zvb11075@nifty.com | |
| Affiliation | Osaka Habikino Medical Center |