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A comparison of continuous inhalation of salbutamol and continuous inhalation of isoproterenol for severe pediatric bronchial asthma: A multicenter, double-blind, randomized study

A comparison of continuous inhalation of salbutamol and continuous inhalation of isoproterenol for severe pediatric bronchial asthma: A multicenter, double-blind, randomized study - A study of continuous inhalation of isoproterenol for severe pediatric bronchial asthma (ICIT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001991
Enrollment
100
Registered
2009-06-08
Start date
2009-06-01
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

Isoproterenol Group: Continuous inhalation of l-isoproterenol(0.01 mg/kg/h
12 hours) + placebo salbutamol and systemic steroid therapy Salbutamon Group: Continuous inhalation of salbutamol(0.5 mg/kg/h
12 hours) + placebo l-isoproterenol and systemic steroid therapy

Sponsors

Dapartment of Pediatrics, Jikei University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Of patients with asthma exacerbation as young as 1 years and as old as 18 years at the time of registration, those with PI (modified pulmonary index) scores of > 14 points without therapy or those with 9 points or more following at least two intermittent (short-acting beta2-agonist: SABA) inhalations within two hours will be enrolled.

Exclusion criteria

Exclusion criteria: Patients with any of the following conditions are excluded: patients with fever (higher than 38.5 centidegree); patients who took an antipyretic drug within six hours; patients with underlying diseases, such as chronic lung disease or cyanotic heart disease, or systemic disease that may cause wheezing; patients with a past history of arrhythmia caused by a beta2-agonist; patients with croup syndrome; patients with suspected foreign-body aspiration; patients with bronchiolitis; patients with pneumonia requiring antibiotic therapy; patients with lobular atelectasis; and patients requiring intratracheal intubation.

Design outcomes

Primary

MeasureTime frame
The degree of change in the mPI scores between baseline and 3 hours after the start of therapy

Secondary

MeasureTime frame
1) The degree of change in the mPI score between baseline and 12 hours after the start of therapy 2) The degree of change in the respiratory rate between baseline and 3 hours after the start of therapy 3) The degree of change in the heart rate between baseline and 3 hours after the start of therapy 4) The degree of improvement at 3 and 12 hours after the start of therapy

Countries

Japan

Contacts

Public ContactToshio Katsunuma

Jikei Daisan Hospital Dapartment of Pediatrics

tkatsunuma@jikei.ac.jp+81-3-3480-1151

Outcome results

None listed

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