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

Primary Purpose

Asthma, Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inhaled Corticosteroid (Budesonide)
Leukotriene Receptor Antagonist (Montelukast Sodium)
Inhaled Albuterol
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Wheezing, Respiratory Tract Illness

Eligibility Criteria

12 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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: 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 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

Sites / Locations

  • University of Arizona, College of Medicine
  • UCSD School of Medicine
  • National Jewish Medical and Research Center
  • Washington University School of Medicine Patient Oriented Research Unit
  • Dept. of Health Evaluation Sciences, Penn State College of Medicine
  • University of Wisconsin - Madison

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Proportion of episode-free days as determined by diary cards

Secondary Outcome Measures

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

Full Information

First Posted
April 27, 2006
Last Updated
July 28, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00319488
Brief Title
Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)
Acronym
AIMS
Official Title
Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Lung Diseases
Keywords
Wheezing, Respiratory Tract Illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily
Arm Title
2
Arm Type
Active Comparator
Arm Description
Active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo ICS plus placebo LTRA plus albuterol inhalation treatments four times daily
Intervention Type
Drug
Intervention Name(s)
Inhaled Corticosteroid (Budesonide)
Intervention Description
Participants will receive inhaled corticosteroid for 7 days, at the first sign of RTI-associated symptoms.
Intervention Type
Drug
Intervention Name(s)
Leukotriene Receptor Antagonist (Montelukast Sodium)
Intervention Description
Participants will receive leukotriene receptor antagonist for 7 days, at the first sign of RTI-associated symptoms.
Intervention Type
Drug
Intervention Name(s)
Inhaled Albuterol
Intervention Description
All participants will receive inhaled albuterol treatments four times a day.
Primary Outcome Measure Information:
Title
Proportion of episode-free days as determined by diary cards
Time Frame
Measured over 12-month follow-up period
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Linear growth
Time Frame
Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility 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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vernon M. Chinchilli, PhD
Organizational Affiliation
Pennsylvania State University, College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona, College of Medicine
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
UCSD School of Medicine
City
LaJolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Washington University School of Medicine Patient Oriented Research Unit
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dept. of Health Evaluation Sciences, Penn State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18973936
Citation
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.
Results Reference
result

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

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