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

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ClinicalTrials.gov Identifier: NCT00319488
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : July 29, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE April 27, 2006
First Posted Date  ICMJE April 27, 2006
Last Update Posted Date July 29, 2016
Study Start Date  ICMJE February 2004
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
Proportion of episode-free days as determined by diary cards [ Time Frame: Measured over 12-month follow-up period ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2006)
Proportion of episode-free days as determined by diary cards (measured over 12-month follow-up period)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Linear growth [ Time Frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2006)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)
Official Title  ICMJE Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • Lung Diseases
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2008)
238
Original Enrollment  ICMJE
 (submitted: April 27, 2006)
225
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00319488
Other Study ID Numbers  ICMJE 386
5U10HL064313-07 ( U.S. NIH Grant/Contract )
5U10HL064287 ( U.S. NIH Grant/Contract )
5U10HL064307 ( U.S. NIH Grant/Contract )
5U10HL064305 ( U.S. NIH Grant/Contract )
5U10HL064288 ( U.S. NIH Grant/Contract )
5U10HL064295 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vernon M. Chinchilli, PhD, Pennsylvania State University, College of Medicine
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vernon M. Chinchilli, PhD Pennsylvania State University, College of Medicine
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date April 2012

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