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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-05

Study Completion Date

2018-08-16

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Status Asthmaticus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Ipratropium

Intervention Type DRUG

Albuterol

Intervention Type DRUG

albuterol prescribed by the clinical team per our PICU's "Asthma Carepath"

corticosteroids

Intervention Type DRUG

systemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV

Placebo

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

Group Type PLACEBO_COMPARATOR

0.9% Sodium Chloride

Intervention Type DRUG

Albuterol

Intervention Type DRUG

albuterol prescribed by the clinical team per our PICU's "Asthma Carepath"

corticosteroids

Intervention Type DRUG

systemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV

Interventions

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Ipratropium

Intervention Type DRUG

0.9% Sodium Chloride

Intervention Type DRUG

Albuterol

albuterol prescribed by the clinical team per our PICU's "Asthma Carepath"

Intervention Type DRUG

corticosteroids

systemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV

Intervention Type DRUG

Other Intervention Names

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Atrovent Duoneb Normal saline methylprednisolone prednisone dexamethasone prednisolone

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No