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

Vanderbilt University Medical Center

Status: Completed

Conditions: Acute Asthma

Treatments: Drug: Albuterol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01196377

100725

K23HL080005 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 4 patient groups

Nebulized albuterol 10mg/hr continuous

Active Comparator group

Description:

Active control arm, 10mg/hr continuous.

Treatment:

Drug: Albuterol

10mg/hr pulsed

Experimental group

Description:

Experimental 10mg/hr pulsed albuterol regimen.

Treatment:

Drug: Albuterol

25mg/hr continuous

Experimental group

Description:

Experimental 25mg/hr continuous albuterol.

Treatment:

Drug: Albuterol

25mg/hr pulsed

Experimental group

Description:

Experimental 25mg/hr pulsed albuterol

Treatment:

Drug: Albuterol