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

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00319488
First received: April 27, 2006
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Asthma
Lung Diseases
Drug: Inhaled Corticosteroid (Budesonide)
Drug: Leukotriene Receptor Antagonist (Montelukast Sodium)
Drug: Inhaled Albuterol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Proportion of episode-free days as determined by diary cards [ Time Frame: Measured over 12-month follow-up period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to initiation of first course of oral corticosteroids [ Time Frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization ] [ Designated as safety issue: Yes ]
  • Total number of courses of oral corticosteroids [ Time Frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization ] [ Designated as safety issue: Yes ]
  • Duration and severity of lower respiratory tract symptoms [ Time Frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization ] [ Designated as safety issue: Yes ]
  • Number of wheezing episodes [ Time Frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization ] [ Designated as safety issue: Yes ]
  • Time to treatment failure [ Time Frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization ] [ Designated as safety issue: Yes ]
  • Measures of patient and family morbidity [ Time Frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization ] [ Designated as safety issue: Yes ]
  • Number of unscheduled visits for acute wheezing episodes [ Time Frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization ] [ Designated as safety issue: Yes ]
  • Linear growth [ Time Frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization ] [ Designated as safety issue: No ]

Enrollment: 238
Study Start Date: February 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily
Drug: Inhaled Corticosteroid (Budesonide)
Participants will receive inhaled corticosteroid 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.
Active Comparator: 2
Active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily
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.
Placebo Comparator: 3
Placebo ICS plus placebo LTRA plus albuterol inhalation treatments four times daily
Drug: Inhaled Albuterol
All participants will receive inhaled albuterol treatments four times a day.

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.

  Eligibility

Ages Eligible for Study:   12 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. 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
    2. 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

Exclusion Criteria:

  • 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
  • History of significant adverse reaction to any study medication ingredient
  • Current participation, or participation in the month prior to study entry, in another investigational drug study
  • Evidence that the family may be unreliable, nonadherent, or likely to move from the clinical center area before study completion
  • Persistent symptomatic asthma, as defined as experiencing symptoms (i.e., nocturnal cough, daytime cough, wheezing, difficulty breathing, or symptoms interfering with activities) and/or requiring albuterol use on average 4 or more days per week in the 2-week observation period prior to the randomization visit
  • The following scores, based on a 5-point scale with 5 representing very severe symptoms (measured at randomization visit): score equal to or greater than one for albuterol use, wheezing, difficulty breathing, nighttime cough, and asthma symptoms interfering with activities; score greater than 2 for daytime cough on an average of 4 or more days/week during the 2-week observation period
  • Failure to complete diary cards at expected levels (at least 80% of days) during the observation period
  • Use of long-term controller medications for asthma (e.g., corticosteroids [inhaled or oral], leukotriene modifiers, cromolyn/nedocromil, or theophylline) during the 2-week observation period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319488

Locations
United States, Arizona
University of Arizona, College of Medicine
Tucson, Arizona, United States, 85724
United States, California
UCSD School of Medicine
LaJolla, California, United States, 92093
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Missouri
Washington University School of Medicine Patient Oriented Research Unit
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
Dept. of Health Evaluation Sciences, Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
United States, Wisconsin
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Investigators
Principal Investigator: Vernon M. Chinchilli, PhD Pennsylvania State University, College of Medicine
  More Information

Publications:
Responsible Party: Vernon M. Chinchilli, PhD, Pennsylvania State University, College of Medicine
ClinicalTrials.gov Identifier: NCT00319488     History of Changes
Other Study ID Numbers: 386, 5U10 HL064313-07, 5U10 HL064287, 5U10 HL064307, 5U10 HL064305, 5U10 HL064288, 5U10 HL064295
Study First Received: April 27, 2006
Last Updated: April 30, 2012
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Wheezing
Respiratory Tract Illness

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Budesonide
Montelukast
Leukotriene Antagonists
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids

ClinicalTrials.gov processed this record on April 17, 2014