Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study

Not Applicable

Completed

• Conditions: Acute Asthma
• Interventions: Drug: Albuterol

• Registration Number: NCT01196377
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-08
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2014-12-10
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-04
• Last Update Submitted: 2017-09-04
• Results First Posted: 2017-09-29
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulized albuterol 10mg/hr continuous	Albuterol	Active control arm, 10mg/hr continuous.
25mg/hr continuous	Albuterol	Experimental 25mg/hr continuous albuterol.
10mg/hr pulsed	Albuterol	Experimental 10mg/hr pulsed albuterol regimen.
25mg/hr pulsed	Albuterol	Experimental 25mg/hr pulsed albuterol

Primary Outcome Measures

Name	Time	Method
%FEV1	2 hours	% predicted forced expiratory volume in 1-second as a measure of airway obstruction