Efficacy of low dose budesonide inhalation suspension / sodium cromoglicate inhalation solution for mild / moderate persistent asthma in young children

Efficacy of low dose budesonide inhalation suspension / sodium cromoglicate inhalation solution for mild / moderate persistent asthma in young children - Efficacy of low dose budesonide inhalation for mild / moderate persistent asthma in young children (Mild One Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003070

Enrollment

Registered

2010-01-21

Start date

2008-05-01

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

BIS administration group Budesonide inhalation suspension 0.25 mg, once daily before bed for 12 weeks using jet nebulizer (PARI TurboBOY N, PARI LC Plus Nebulizer) CIS administration group Sodium cr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Mild to moderate persistent asthma patients (JPGL 2005, Pediatr Int. 2007 Dec;49(6):1023-31)

Exclusion criteria

Exclusion criteria: 1. Patients who have a case listed below within a month a)Severe respiratory infection disease that required hospitalization b)Administration of systemic steroid 2. Patients who have underlying disease that indicate chronic airway symptom exclude asthma

Design outcomes

Primary

Measure	Time frame
Daytime and nighttime symptom score at baseline and after 12 weeks of administration (0-3 point scale).	—

Secondary

Measure	Time frame
- Score of symptom (based on asthma diary, 0-9 point scale) - Frequency of use inhaled short acting beta2 agonist(SABA) - Level of blood serum cortisol at baseline and end of study - Level of blood serum ECP at baseline and end of study - Unscheduled hospital visits and emergency room visit because of asthma exacerbation - Adverse events	—

Countries

Japan

Contacts

Public ContactToshio Katsunuma

Jikei University School of Medicine Department of Pediatrics

Outcome results

None listed

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