Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus

• Status: Completed
• Trial end date: 2018-08-16
• Target enrollment: 0
• Participant gender: All

Summary

This study is a Phase I study to investigate the addition of inhaled Ipratropium bromide to standard therapy in the treatment of severe asthma attacks in children admitted to the Pediatric Intensive Care Unit. Half of the subjects will receive inhaled Ipratropium, and half will receive an inhaled placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Treatments: Albuterol; Dexamethasone; Ipratropium; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

Inclusion Criteria:

• Admission to the PICU

• Treatment with continuous albuterol via the Asthma Carepath

• Enrollment occurred within 4 hours of starting continuous albuterol in the PICU

• Treatment with systemic corticosteroids by the clinical team

Exclusion Criteria:

• First episode of wheezing that prompted treatment with bronchodilators by medical personnel

• Prior enrollment in this study

• Patients with chronic lung disease requiring routine home oxygen use

• Allergy to inhaled ipratropium or inhaled saline

• Positive pressure ventilation (via an endotracheal tube or a non-invasive mask [e.g. CPAP (continuous positive airway pressure) or BiPAP])

• Pregnancy

• Tracheostomy

• Age < 2 years

• Age > 17 years

• Patient with pulmonary hypertension requiring daily therapy

• Patient with cyanotic congenital heart disease

• Cystic fibrosis