Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study

Our overall objective is to model a pediatric Acute Asthma Clinical Decision Rule (ADR) for personalized medicine by identification of treatment-response phenotypes that are important determinants of outcome. The Specific Aim of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.

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Key information

Conditions

Acute Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The objective of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Participants are randomized in randomly permuted blocks of four. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Doctor diagnosed asthma
Acute asthma exacerbation
Treatment with systemic corticosteroids and nebulized albuterol
Ages 5 to 17 years

Exclusion criteria

Other acute or chronic lung disease

Treatment and study plan

albuterol

Drug

Nebulized albuterol

Other names: proventil

Primary outcomes

%FEV1

Time frame: 2 hours

% predicted forced expiratory volume in 1-second as a measure of airway obstruction

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Personalized Medicine, Biomarker-based Study of Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study

Acronym: OARS

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Sep 8, 2010
Registry last updated: Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed