- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01196377
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
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.
|
Nebulized albuterol
Other Names:
|
Experimental: 10mg/hr pulsed
Experimental 10mg/hr pulsed albuterol regimen.
|
Nebulized albuterol
Other Names:
|
Experimental: 25mg/hr continuous
Experimental 25mg/hr continuous albuterol.
|
Nebulized albuterol
Other Names:
|
Experimental: 25mg/hr pulsed
Experimental 25mg/hr pulsed albuterol
|
Nebulized albuterol
Other Names:
|
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.
Collaborators
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
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
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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