Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus
| Status: | Recruiting |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 10/27/2017 |
| Start Date: | September 5, 2016 |
| End Date: | September 2018 |
| Contact: | Steven Shein, MD |
| Email: | steven.shein@uhhospitals.org |
| Phone: | 216-368-2329 |
A Phase I, Single Center, Placebo-Controlled, Blinded Pilot Study of Ipratropium Bromide in Children Admitted to the Intensive Care Unit With Status Asthmaticus
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.
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.
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).
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).
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
We found this trial at
1
site
Cleveland, Ohio 44106
Phone: 216-368-2329
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