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JAPANESE
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) studiedfood allergy
Date of first enrollment10/02/2026
Target sample size40
Countries of recruitment
Study typeInterventional
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 OutcomeProportion of patients who had an improvement in the face scale of abdominal pain under 2 within 20 minutes after salbutamol inhalation
Secondary OutcomeProportion 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
GenderBoth
Include criteriaPatients 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 criteriaIndividuals 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

Contact

Public contact
Name Yuri Takaoka
Address 3-7-1, Habikino, Habikino city, Osaka Osaka Japan 583-8588
Telephone +81-72-957-2121
E-mail 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
E-mail zvb11075@nifty.com
Affiliation Osaka Habikino Medical Center