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

UMIN ID: UMIN000001991

Registered date:08/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: bronchial asthma
• Date of first enrollment: 2009/06/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: The degree of change in the mPI scores between baseline and 3 hours after the start of therapy
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 1years-old
• Age maximum: 18years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Dapartment of Pediatrics, Jikei University School of Medicine
• Source(s) of Monetary Support: Ministry of Health, Labor and Welfare Scientific Research Fund: Basic research for clinical application