NCT01196377

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
7 years until next milestone

Results Posted

Study results publicly available

September 29, 2017

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

1 month

First QC Date

September 3, 2010

Results QC Date

December 10, 2014

Last Update Submit

September 4, 2017

Conditions

Acute Asthma

Keywords

AsthmaAcute asthmaPediatrics

Outcome Measures

Primary Outcomes (1)

  • %FEV1

    % predicted forced expiratory volume in 1-second as a measure of airway obstruction

    2 hours

Study Arms (4)

Nebulized albuterol 10mg/hr continuous

ACTIVE COMPARATOR

Active control arm, 10mg/hr continuous.

Drug: Albuterol

10mg/hr pulsed

EXPERIMENTAL

Experimental 10mg/hr pulsed albuterol regimen.

Drug: Albuterol

25mg/hr continuous

EXPERIMENTAL

Experimental 25mg/hr continuous albuterol.

Drug: Albuterol

25mg/hr pulsed

EXPERIMENTAL

Experimental 25mg/hr pulsed albuterol

Drug: Albuterol

Interventions

AlbuterolDRUG

Nebulized albuterol

Also known as: proventil
10mg/hr pulsed25mg/hr continuous25mg/hr pulsedNebulized albuterol 10mg/hr continuous

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Doctor diagnosed asthma
  • Acute asthma exacerbation
  • Treatment with systemic corticosteroids and nebulized albuterol
  • Ages 5 to 17 years

You may not qualify if:

  • Other acute or chronic lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Limitations and Caveats

Limitations: small sample size and not powered to detect differences in outcomes (pilot feasibility study).

Results Point of Contact

Title
Dr. Donald H Arnold
Organization
Vanderbilt University School of Medicine
don.arnold@vanderbilt.edu
6155790516

Study Officials

  • Donald H Arnold, MD, MPH

    Vanderbilt University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics and Emergency Medicine

Study Record Dates

First Submitted

September 3, 2010

First Posted

September 8, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

September 29, 2017

Results First Posted

September 29, 2017

Record last verified: 2017-09