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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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