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

April 27, 2006
April 30, 2012
February 2004
November 2006   (final data collection date for primary outcome measure)
Proportion of episode-free days as determined by diary cards [ Time Frame: Measured over 12-month follow-up period ] [ Designated as safety issue: Yes ]
Proportion of episode-free days as determined by diary cards (measured over 12-month follow-up period)
Complete list of historical versions of study NCT00319488 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time to initiation of first course of oral corticosteroids
  • Total number of courses of oral corticosteroids
  • Duration and severity of lower respiratory tract symptoms
  • Number of wheezing episodes
  • Time to treatment failure
  • Measures of patient and family morbidity
  • Number of unscheduled visits for acute wheezing episodes
  • Linear growth (all measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
Not Provided
Not Provided
 
Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)
Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Asthma
  • Lung Diseases
  • 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.
  • Active Comparator: 1
    Active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily
    Interventions:
    • Drug: Inhaled Corticosteroid (Budesonide)
    • Drug: Inhaled Albuterol
  • Active Comparator: 2
    Active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily
    Interventions:
    • Drug: Leukotriene Receptor Antagonist (Montelukast Sodium)
    • Drug: Inhaled Albuterol
  • Placebo Comparator: 3
    Placebo ICS plus placebo LTRA plus albuterol inhalation treatments four times daily
    Intervention: Drug: Inhaled Albuterol
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. Epub 2008 Oct 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
238
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
12 Months to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00319488
386, 5U10 HL064313-07, 5U10 HL064287, 5U10 HL064307, 5U10 HL064305, 5U10 HL064288, 5U10 HL064295
Yes
Vernon M. Chinchilli, PhD, Pennsylvania State University, College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Principal Investigator: Vernon M. Chinchilli, PhD Pennsylvania State University, College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP