N/A N=16 Randomized Quadruple-blind Treatment

Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study

Acute Asthma

Bottom Line

View on ClinicalTrials.gov: NCT01196377 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2017

Primary outcome: Primary: %FEV1 — 20; 34; 26; 31 %-predicted

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Albuterol (Drug)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY %FEV1	20; 34; 26; 31; 41; 47	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01196377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.