Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

This study has been completed.

First Received: July 27, 2005 Last Updated: September 7, 2006 History of Changes

Sponsored by:	Connecticut Children's Medical Center
Information provided by:	Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:	NCT00124995

Purpose

Although widely used for the treatment of pediatric status asthmaticus, intravenous terbutaline has potentially significant side effects; may not improve outcomes; and may increase Intensive Care Unit (ICU) length of stay. This study is designed to test the efficacy of intravenous terbutaline for the treatment of status asthmaticus by adding intravenous terbutaline or placebo to standard asthma treatment. The dose of terbutaline or placebo will be titrated according to severity of illness as quantified by a validated clinical asthma score. Differences in outcomes between the study groups, such as length of stay, hospital costs, and lung function will be compared.

Condition	Intervention	Phase
Status Asthmaticus	Drug: terbutaline	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Double-Blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Terbutaline Terbutaline sulfate

U.S. FDA Resources

Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:

ICU length of stay

Secondary Outcome Measures:

To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
To prospectively analyze the side effects of terbutaline

Estimated Enrollment:	40
Study Start Date:	October 2003

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Admission to the Connecticut Children's Medical Center (CCMC) Pediatric Intensive Care Unit (PICU) with a primary admission diagnosis of status asthmaticus
Modified Pulmonary Index Score (MPIS) of greater than or equal to 12
Age between birth and 18 years old

Exclusion Criteria:

Pre-existing cardiac or pulmonary disease
Existing respiratory failure (requiring invasive or non-invasive mechanical ventilation)
Hemodynamic or cardiovascular instability requiring inotropic support
The patient meets one of the criteria for withdrawal from the study due to patient safety concerns

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124995

Locations

United States, Connecticut
CT Children's Medical Center
Hartford, Connecticut, United States, 06106

Sponsors and Collaborators

Connecticut Children's Medical Center

Investigators

Principal Investigator:

Christopher Carroll, MD

CT Children's Medical Center

More Information

No publications provided

Study ID Numbers:	05-001
Study First Received:	July 27, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00124995 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Adrenergic beta-Agonists
Status Asthmaticus
Asthma
Anti-Asthmatic Agents
Adrenergic Agonists

Terbutaline
Hypersensitivity
Respiratory Tract Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Reproductive Control Agents
Adrenergic Agonists
Terbutaline
Hypersensitivity
Respiratory Tract Diseases
Tocolytic Agents
Therapeutic Uses

Immune System Diseases
Adrenergic beta-Agonists
Sympathomimetics
Status Asthmaticus
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions
Autonomic Agents
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on July 02, 2009