NCT00319488

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · NIH
• Sex: All
• Age: 12 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Acute Intervention Management Strategies (AIMS) is a randomized, double-blind, double-dummy, placebo-controlled parallel comparison study that will compare the effectiveness of three treatments, when given at the onset of RTI-associated symptoms, in increasing the proportion of symptom-free days over the entire treatment period of the 5- to 9-month study. There will be a 2-week period to qualify and characterize participants, who at that time will have no lower respiratory tract symptoms other than mild cough. A total of 244 participants will be randomized to one of three treatment groups and followed for the remainder of the fall-winter-early spring season. Participants will receive one of the following treatment regimens for 7 days, at the first sign of RTI-associated symptoms: 1) active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily; 2) active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily; or 3) placebo ICS plus placebo LTRA plus albuterol inhalation treatments four times daily.

Conditions

• Asthma
• Lung Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-02-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2006-04-27
• Last updated: 2016-07-29

Locations

6 sites across 1 country: United States