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

April 17, 2019 updated by: Steven Shein, University Hospitals Cleveland Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Inhaled ipratropium bromide 250mcg given via nebulization every 6 hours for up to 5 days
Drug: Ipratropium
Other Names:
  • Atrovent
  • Duoneb
Drug: Albuterol
albuterol prescribed by the clinical team per our PICU's "Asthma Carepath"
Drug: corticosteroids
systemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV
Other Names:
  • prednisolone
  • dexamethasone
  • methylprednisolone
  • prednisone
Placebo Comparator: Placebo
Inhaled normal saline 1.25mL given via nebulization every 6 hours for up to 5 days
Drug: Albuterol
albuterol prescribed by the clinical team per our PICU's "Asthma Carepath"
Drug: corticosteroids
systemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV
Other Names:
  • prednisolone
  • dexamethasone
  • methylprednisolone
  • prednisone
Drug: 0.9% Sodium Chloride
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to q2 Albuterol
Time Frame: typically 12-48 hours
In our PICU, status asthmaticus patients are initially treated with continuous nebulization of albuterol. Per a standard assessment/scoring system, the patients are re-assessed each hour. When the patient's symptoms have sufficiently improved, the albuterol is weaned to 2.5mg given every 1hr ("q1hr albuterol") and, subsequently, to 2.5mg given every 2 hours ("q2hr Albuterol"). This outcome will measure the interval between the initiation of continuous albuterol and the second dose of q2hr Albuterol.
typically 12-48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PICU LOS (length of stay)
Time Frame: This outcome is assessed continually over the course of the study, typically 24-72 hours
The time interval between admission to the PICU and discharge from the PICU, typically to the general ward. Patients are typically transferred to the general ward when they are receiving albuterol every 3 hours.
This outcome is assessed continually over the course of the study, typically 24-72 hours
Hospital LOS (length of stay)
Time Frame: This outcome is assessed continually over the course of the study, typically 48-120 hours
The time interval between admission to the hospital and discharge from the hospital. Patients are typically discharged from the hospital when they are receiving albuterol every 4 hours.
This outcome is assessed continually over the course of the study, typically 48-120 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dry eyes
Time Frame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Report of dry eyes from the patient, their family or their clinical provider
Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Dry mouth
Time Frame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Report of dry mouth from the patient, their family or their clinical provider
Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Tremor
Time Frame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Report of tremor from the patient, their family or their clinical provider
Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Blurred vision
Time Frame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Report of blurred vision from the patient, their family or their clinical provider
Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Urinary retention
Time Frame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Report of urinary retention from the patient, their family or their clinical provider
Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Headache
Time Frame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Report of headache from the patient, their family or their clinical provider
Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Nausea/abdominal pain
Time Frame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Report of nausea/abdominal pain from the patient, their family or their clinical provider
Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2016

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

August 16, 2018

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #02-16-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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