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Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)

NCT00319488 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2016-07-29

No results posted yet for this study

Summary

This study will determine the effectiveness of initiating a high-dose inhaled corticosteroid (ICS) or a leukotriene receptor antagonist (LTRA) in addition to an inhaled beta2-agonist (albuterol) at the onset of respiratory tract illness (RTI)-associated symptoms in increasing episode-free days among young children with recurrent severe wheezing.

Conditions

Interventions

DRUG

Inhaled Corticosteroid (Budesonide)

Participants will receive inhaled corticosteroid for 7 days, at the first sign of RTI-associated symptoms.

DRUG

Leukotriene Receptor Antagonist (Montelukast Sodium)

Participants will receive leukotriene receptor antagonist for 7 days, at the first sign of RTI-associated symptoms.

DRUG

Inhaled Albuterol

All participants will receive inhaled albuterol treatments four times a day.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Vernon M. Chinchilli, PhD · Pennsylvania State University, College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00319488 on ClinicalTrials.gov