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

NCT00319488 | Completed DMC

• 7 other identifiers: 3865U10HL064313-075U10HL0642875U10HL0643075U10HL0643055U10HL0642885U10HL064295
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 6

Brief 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

Asthma; Lung Diseases

Keywords

Wheezing; Respiratory Tract Illness

Outcome Measures

Primary Outcomes (1)

• Proportion of episode-free days as determined by diary cards

  Measured over 12-month follow-up period

Secondary Outcomes (8)

• Time to initiation of first course of oral corticosteroids

  Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization

• Total number of courses of oral corticosteroids

  Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization

• Duration and severity of lower respiratory tract symptoms

  Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization

• Number of wheezing episodes

  Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization

• Time to treatment failure

  Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization

Study Arms (3)

1

ACTIVE COMPARATOR

Active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily

Drug: Inhaled Corticosteroid (Budesonide); Drug: Inhaled Albuterol

2

ACTIVE COMPARATOR

Active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily

Drug: Leukotriene Receptor Antagonist (Montelukast Sodium); Drug: Inhaled Albuterol

3

PLACEBO COMPARATOR

Placebo ICS plus placebo LTRA plus albuterol inhalation treatments four times daily

Drug: Inhaled Albuterol

Interventions

Inhaled Corticosteroid (Budesonide) DRUG

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

1

Leukotriene Receptor Antagonist (Montelukast Sodium) DRUG

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

2

Inhaled Albuterol DRUG

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

1; 2; 3

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Recurrent episodes (at least two) of wheezing in the context of a RTI, at least one of which must be documented by a health care provider (parental report) over the 12 months prior to study entry, and of which one episode must have occurred within 6 months prior to study entry
• Either two episodes of '1,' OR two episodes of '2,' OR one episode of '1' AND one episode of '2,' defined by the following:
• Urgent care visit for acute wheezing (emergency department, urgent care center, or unscheduled primary care physician office visit), which required treatment with a bronchodilator, within 12 months prior to study entry
• Episode of wheezing within 12 months prior to study entry, which required treatment with oral corticosteroids not associated with a visit to a health care provider, urgent care center, emergency department, or hospital
• Immunizations are up to date, including varicella (unless the patient has already had clinical varicella)
• Willingness to provide informed consent by patient's parent or guardian

You may not qualify if:

• Use of more than six courses of systemic corticosteroids during the 12 months prior to study entry
• More than two hospitalizations for wheezing illnesses within 12 months prior to study entry
• Use of long-term controller medications for asthma (including inhaled corticosteroids, leukotriene modifiers, cromolyn/nedocromil, or theophylline) for 4 or more months (cumulative use) within 1 year prior to study entry
• Any use of long-term controller medications for asthma (including corticosteroids \[inhaled or oral\], leukotriene modifiers, cromolyn/nedocromil, or theophylline) within the 2 weeks prior to the enrollment visit
• Current treatment with antibiotics for diagnosed sinus disease
• Contraindication of use of systemic corticosteroids
• Prematurity (defined as birth before 36 weeks gestational age)
• Presence of lung disease other than asthma (e.g., cystic fibrosis and BPD)
• Presence of other significant medical illnesses (e.g., cardiac, liver, gastrointestinal, or endocrine disease) that would place the patient at increased risk
• Gastroesophageal reflux under medical therapy
• Immunodeficiency disorders
• History of respiratory failure requiring mechanical ventilation
• History of hypoxic seizure
• Inability to cooperate with nebulization therapy
• Inability to ingest the study drugs

Sponsors & Collaborators

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

Study Sites (6)

University of Arizona, College of Medicine

Tucson, Arizona, 85724, United States

Location

UCSD School of Medicine

La Jolla, California, 92093, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

Washington University School of Medicine Patient Oriented Research Unit

St Louis, Missouri, 63110, United States

Location

Dept. of Health Evaluation Sciences, Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Bacharier LB, Phillips BR, Zeiger RS, Szefler SJ, Martinez FD, Lemanske RF Jr, Sorkness CA, Bloomberg GR, Morgan WJ, Paul IM, Guilbert T, Krawiec M, Covar R, Larsen G, Mellon M, Moss MH, Chinchilli VM, Taussig LM, Strunk RC; CARE Network. Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing. J Allergy Clin Immunol. 2008 Dec;122(6):1127-1135.e8. doi: 10.1016/j.jaci.2008.09.029. Epub 2008 Oct 30.

  PMID: 18973936 RESULT

• Fitzpatrick AM, Grunwell JR, Cottrill KA, Mutic AD, Mauger DT. Blood Eosinophils for Prediction of Exacerbation in Preschool Children With Recurrent Wheezing. J Allergy Clin Immunol Pract. 2023 May;11(5):1485-1493.e8. doi: 10.1016/j.jaip.2023.01.037. Epub 2023 Feb 3.

  PMID: 36738927 DERIVED

MeSH Terms

Conditions

Asthma; Lung Diseases; Respiratory Sounds

Interventions

Budesonide; Leukotriene Antagonists; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Vernon M. Chinchilli, PhD

  Pennsylvania State University, College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Study Start: February 1, 2004
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: July 29, 2016

Record last verified: 2012-04

Locations

US (6)