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Efficacy of three Different Budesonide Treatments in Chinese Preschool Children with Recurrent Wheezing

Efficacy of three Different Budesonide Treatments in Chinese Preschool Children with Recurrent Wheezing

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031893
Enrollment
Unknown
Registered
2020-04-13
Start date
2015-01-01
Completion date
Unknown
Last updated
2020-04-20

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

Conditions

Recurrent Wheezing

Interventions

daily group:initially given inhaled BUD 1 mg once a day, assessed every 4 weeks
if the symptom was well controlled and maintained for 12 weeks, the dose was reduced to 25%-50% of the previous dose until the final dose was 0.25 mg, once a day, maintained to 52 weeks)
an intermittent high-dose group:1 mg twice daily for 7 days, starting early during a predefined respiratory tract illness
an intermittent medium-dose group:0.5 mg twice daily as soon as they contacted allergens or had nasal congestion, a runny nose, cough or any other suspicious respiratory symptoms, continuing until the

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 5 Years

Inclusion criteria

Inclusion criteria: 1. mAPI positive children; 2. have >=4 wheezing episodes in the past year; 3. meeting at least 1 major criterion or at least 2 minor criteria. The major criteria include parental history of asthma, physician-diagnosed atopic dermatitis, and allergic sensitization to at least 1 aeroallergen. The minor criteria include wheezing unrelated to colds, peripheral blood eosinophils >=4%, and allergic sensitization to milk, egg, or peanuts.

Exclusion criteria

Exclusion criteria: 1. their wheezing was caused by organic lesions and mechanical factors; 2. had received more than six systemic glucocorticoids or had been hospitalized more than two times within 52-weeks; 3. had used other asthma control drugs; 4. their guardians did not know the childs medical history or did not agree to participate in the study.

Design outcomes

Primary

MeasureTime frame
The Test for Respiratory and Asthma Control in Kids scores;

Secondary

MeasureTime frame
the number of systemic corticosteroids courses during the 52-week treatment period.;the number of wheezing episodes during the 52-week treatment period.;urgent care visits for wheezing during the 52-week treatment period.;

Countries

China

Contacts

Public ContactPing Sun

The First Affiliated Hospital of Nanchang University

supping158@163.com+86 13970035358

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026