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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01196377
First Posted: September 8, 2010
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Donald H Arnold, Vanderbilt University Medical Center
  Purpose
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.

Condition Intervention
Acute Asthma Drug: Albuterol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Personalized Medicine, Biomarker-based Study of Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study

Resource links provided by NLM:


Further study details as provided by Donald H Arnold, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • %FEV1 [ Time Frame: 2 hours ]
    % predicted forced expiratory volume in 1-second as a measure of airway obstruction


Enrollment: 16
Study Start Date: September 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nebulized albuterol 10mg/hr continuous
Active control arm, 10mg/hr continuous.
Drug: Albuterol
Nebulized albuterol
Other Name: proventil
Experimental: 10mg/hr pulsed
Experimental 10mg/hr pulsed albuterol regimen.
Drug: Albuterol
Nebulized albuterol
Other Name: proventil
Experimental: 25mg/hr continuous
Experimental 25mg/hr continuous albuterol.
Drug: Albuterol
Nebulized albuterol
Other Name: proventil
Experimental: 25mg/hr pulsed
Experimental 25mg/hr pulsed albuterol
Drug: Albuterol
Nebulized albuterol
Other Name: proventil

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196377


Sponsors and Collaborators
Vanderbilt University Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Donald H Arnold, MD, MPH Vanderbilt University School of Medicine
  More Information

Responsible Party: Donald H Arnold, Associate Professor of Pediatrics and Emergency Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01196377     History of Changes
Other Study ID Numbers: 100725
K23HL080005 ( U.S. NIH Grant/Contract )
First Submitted: September 3, 2010
First Posted: September 8, 2010
Results First Submitted: December 10, 2014
Results First Posted: September 29, 2017
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by Donald H Arnold, Vanderbilt University Medical Center:
Asthma
Acute asthma
Pediatrics

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action