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| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00319488 |
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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS) |
| 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 |
|---|---|
|
1: Active Comparator
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.
|
|
2: Active Comparator
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.
|
|
3: Placebo Comparator
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.
|
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 |
Inclusion Criteria:
Either two episodes of '1,' OR two episodes of '2,' OR one episode of '1' AND one episode of '2,' defined by the following:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Vernon M. Chinchilli, PhD | Pennsylvania State University, College of Medicine |
More Information
| Responsible Party: | Pennsylvania State University, College of Medicine ( Vernon M. Chinchilli, PhD ) |
| 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: | July 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00319488 History of Changes |
| Health Authority: | United States: Federal Government |
|
Wheezing Respiratory Tract Illness |
|
Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Hormone Antagonists Albuterol Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Asthma Hormones |
Adrenergic Agonists Leukotriene Antagonists Montelukast Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
|
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchial Diseases Adrenergic Agents Hormone Antagonists Albuterol Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Adrenergic Agonists Leukotriene Antagonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases |
Tocolytic Agents Therapeutic Uses Immune System Diseases Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Pharmacologic Actions Montelukast Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |