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| Sponsor: | 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: | 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) |
| 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.
|
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: | 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: | July 28, 2008 |
| Health Authority: | United States: Federal Government |
|
Wheezing Respiratory Tract Illness |
|
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 |