Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study

Acute Asthma Clinical Trial

— OARS  

Official title:

Personalized Medicine, Biomarker-based Study of Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196377
• Other study ID #: 100725
• Secondary ID: K23HL080005
• Status: Completed
• Phase: N/A
• First received: September 3, 2010
• Last updated: September 4, 2017
• Start date: September 2010
• Est. completion date: October 2010

Study information

• Verified date: September 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Asthma
• Asthma

Intervention

Drug:
• Albuterol
Nebulized albuterol

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%FEV1	% predicted forced expiratory volume in 1-second as a measure of airway obstruction	2 hours