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Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study

NCT ID: NCT01196377

Last Updated: 2017-09-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nebulized albuterol 10mg/hr continuous

Active control arm, 10mg/hr continuous.

Group Type ACTIVE_COMPARATOR

Albuterol

Intervention Type DRUG

Nebulized albuterol

10mg/hr pulsed

Experimental 10mg/hr pulsed albuterol regimen.

Group Type EXPERIMENTAL

Albuterol

Intervention Type DRUG

Nebulized albuterol

25mg/hr continuous

Experimental 25mg/hr continuous albuterol.

Group Type EXPERIMENTAL

Albuterol

Intervention Type DRUG

Nebulized albuterol

25mg/hr pulsed

Experimental 25mg/hr pulsed albuterol

Group Type EXPERIMENTAL

Albuterol

Intervention Type DRUG

Nebulized albuterol

Interventions

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Albuterol

Nebulized albuterol

Intervention Type DRUG

Other Intervention Names

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proventil

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Donald H Arnold

Associate Professor of Pediatrics and Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donald H Arnold, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University School of Medicine

Other Identifiers

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K23HL080005

Identifier Type: NIH

Identifier Source: secondary_id

View Link

100725

Identifier Type: -

Identifier Source: org_study_id