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

University Hospitals (UH)

Status and phase: Completed; Phase 1

Conditions: Status Asthmaticus

Treatments: Drug: 0.9% Sodium Chloride; Drug: Albuterol; Drug: corticosteroids; Drug: Ipratropium

Study type: Interventional

Funder types: Other

Identifiers

NCT02872597

IRB #02-16-18

Details and patient eligibility

About

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.

Full description

Status asthmaticus is an acute exacerbation of asthma that often requires treatment in a pediatric intensive care unit (PICU). Standard therapies for status asthmaticus include corticosteroids and bronchodilators, typically albuterol. Ipratropium bromide is also a bronchodilator, but has a different mechanism of action than albuterol. The addition of Ipraropium to children in the Emergency Room with severe asthma exacerbations improves outcomes, so many PICU doctors treat patients with status asthmaticus with Ipratropium. However, two studies of children hospitalized in the general wards of the hospital (not the PICU) show that the addition of Ipratropium to standard care does not effect clinical outcomes. This study is a first step towards determining in Ipratropium is helpful in PICU patients (like it is in ER patients) or if it not helpful (like it is in general ward patients).

Enrollment: 30 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Inhaled ipratropium bromide 250mcg given via nebulization every 6 hours for up to 5 days

Treatment:

Drug: Ipratropium

Drug: Albuterol

Drug: corticosteroids

Placebo

Placebo Comparator group

Description:

Inhaled normal saline 1.25mL given via nebulization every 6 hours for up to 5 days

Treatment:

Drug: Albuterol

Drug: corticosteroids

Drug: 0.9% Sodium Chloride