Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study (OARS)

September 4, 2017 updated by: Donald H Arnold, Vanderbilt University Medical Center

Personalized Medicine, Biomarker-based Study of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

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

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
Active Comparator: Nebulized albuterol 10mg/hr continuous
Active control arm, 10mg/hr continuous.
Drug: Albuterol
Nebulized albuterol
Other Names:
  • proventil
Experimental: 10mg/hr pulsed
Experimental 10mg/hr pulsed albuterol regimen.
Drug: Albuterol
Nebulized albuterol
Other Names:
  • proventil
Experimental: 25mg/hr continuous
Experimental 25mg/hr continuous albuterol.
Drug: Albuterol
Nebulized albuterol
Other Names:
  • proventil
Experimental: 25mg/hr pulsed
Experimental 25mg/hr pulsed albuterol
Drug: Albuterol
Nebulized albuterol
Other Names:
  • proventil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%FEV1
Time Frame: 2 hours
% predicted forced expiratory volume in 1-second as a measure of airway obstruction
2 hours

Collaborators and Investigators

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

Sponsor

Vanderbilt University Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Donald H Arnold, MD, MPH, Vanderbilt University School of Medicine

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

September 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

September 3, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 8, 2010

Study Record Updates

Last Update Posted (Actual)

September 29, 2017

Last Update Submitted That Met QC Criteria

September 4, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100725
  • K23HL080005 (U.S. NIH Grant/Contract)

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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