Efficacy and safety of regular treatment with procaterol and budesonide inhalation suspension for young children with moderate persistent asthma.

Efficacy and safety of regular treatment with procaterol and budesonide inhalation suspension for young children with moderate persistent asthma. - Budesonide + Procaterol Inhalation Therapy Study (BUPIT study)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003492

Enrollment

Registered

2010-04-14

Start date

2010-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma

Interventions

GROUP B + P (budesonide + procaterol) Phase 1: 4 weeks Inhalation of the mixture of procaterol(0.3ml for &gt

15kg, 0.15ml for &lt

15kg) and budesonide inhalation suspension(0.25mg), twice a day, using jet nebulizer (PARI TurboBOY N,PALI LC Plus Nebulizer) Phase 2: 4 weeks after phase 1 Inhalation of budesonide inhalation suspe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Children with persistent asthma -Age : children over six months under five years of age -Severity : moderate according to the criteria of JPGL 2008 2.Children who (whose parents) have given informed consent for participation in the present study.

Exclusion criteria

Exclusion criteria: 1.Patients who have an event listed below within a month a)Respiratory infection disease that required hospitalization b)Administration of systemic corticosteroids 2.Recieving regular use of inhaled corticosteroids or beta 2 agonists in the previous 3 months 3.Patients who have severe chronic diseases 4.Patients who have chronic low airway diseases other than bronchial asthma 5.Any other children considered by the attending physicians as inappropriate for participation in this study

Design outcomes

Primary

Measure	Time frame
Symptom free days (Sympton is cough and wheezing and dyspnea and sleep disturbance)	—

Secondary

Measure	Time frame
1.Score of symptom (base on asthma diary) 2.Frequency of inhaled short acting beta 2 agonist (SABA) use 3.Unscheduled hospital visits and emergency room visits because of asthma exacerbation 4.Count of blood eosinophil at baseline and end of phase 1 (end of phase 2,if possible) 5.Level of blood serum cortisol at baseline and end of phase 1 (end of phase 2,if possible) 6.QOL test at baseline and end of phase 1 (end of phase 2,if possible) 7.exhaled nitric oxide (only the child can be examined) 8.PEFR:morning and evening (only the child can be examined) 9.Adverse events	—

Measure

Time frame

1.Score of symptom (base on asthma diary) 2.Frequency of inhaled short acting beta 2 agonist (SABA) use 3.Unscheduled hospital visits and emergency room visits because of asthma exacerbation 4.Count of blood eosinophil at baseline and end of phase 1 (end of phase 2,if possible) 5.Level of blood serum cortisol at baseline and end of phase 1 (end of phase 2,if possible) 6.QOL test at baseline and end of phase 1 (end of phase 2,if possible) 7.exhaled nitric oxide (only the child can be examined) 8.PEFR:morning and evening (only the child can be examined) 9.Adverse events

—

Countries

Japan

Contacts

Public ContactYuichi Adachi

University of Toyama, Faculty of Medicine Department of Pediatrics

076-434-7313

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026