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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Donald H Arnold, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01196377
First received: September 3, 2010
Last updated: June 19, 2012
Last verified: June 2012
  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
Moderate and Severe Acute Asthma Exacerbations in Pediatric Patients
Drug: Albuterol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Vanderbilt University:

Primary Outcome Measures:
  • FEV1 [ Time Frame: 0, 40, 80 and 120 minutes ] [ Designated as safety issue: No ]

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
Experimental: 10mg/hr pulsed
Experimental 10mg/hr pulsed albuterol regimen.
Drug: Albuterol
Nebulized albuterol
Experimental: 25mg/hr continuous
Experimental 25mg/hr continuous albuterol.
Drug: Albuterol
Nebulized albuterol
Experimental: 25mg/hr pulsed
Experimental 25mg/hr pulsed
Drug: Albuterol
Nebulized albuterol

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196377

Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Donald H Arnold, MD, MPH Vanderbilt University School of Medicine
  More Information

No publications provided

Responsible Party: Donald H Arnold, Associate Professor of Pediatrics and Emergency Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01196377     History of Changes
Other Study ID Numbers: 100725, K23HL080005
Study First Received: September 3, 2010
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Asthma
Acute asthma
Pediatrics

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

ClinicalTrials.gov processed this record on October 21, 2014