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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00394329 |
Asthma is a common, serious illness among children in the United States. It can be effectively controlled through the use of preventative medications and "rescue" medications, which are used to control symptoms. This study will evaluate the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving various combinations of medications for daily and rescue use.
Condition | Intervention | Phase |
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Asthma |
Drug: Beclomethasone dipropionate Drug: Albuterol sulfate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Childhood Asthma Research and Education (CARE) Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA) |
Estimated Enrollment: | 280 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Beclomethasone diproprionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone diproprionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed
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Drug: Beclomethasone dipropionate
Beclomethasone diproprionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Drug: Beclomethasone dipropionate
Beclomethasone diproprionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
Drug: Albuterol sulfate
Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
B: Active Comparator
Beclomethasone diproprionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
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Drug: Beclomethasone dipropionate
Beclomethasone diproprionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Drug: Albuterol sulfate
Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
C: Experimental
Beclomethasone diproprionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
Drug: Beclomethasone dipropionate
Beclomethasone diproprionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
Drug: Albuterol sulfate
Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
D: Placebo Comparator
Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
Drug: Albuterol sulfate
Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
Almost 9 million children in the United States have asthma, and it is a leading cause of hospitalizations and school absenteeism. Common asthma symptoms include wheezing, shortness of breath, chest tightness, and coughing. While there is no cure for asthma, most children who receive proper treatment are able to control symptoms and lead a normal life. Asthma is commonly treated with two types of medications: long-term control medication, such as inhaled corticosteroids (ICS), which is taken on a regular schedule to prevent symptoms and keep asthma under control, and quick-relief, or "rescue" medication, such as albuterol, which is used on an as-needed-basis with the onset of symptoms or an asthma attack. The purpose of this study is to assess the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving ICS on a daily basis plus ICS and albuterol as rescue medications.
This study will begin with a 4-week screening period during which participants will be monitored while they use an inhaler with a low dose of ICS medication. Study visits will occur at study entry and Week 4. Participants will undergo a physical examination, lung function and airway pressure testing, and blood collection. At the Week 4 study visit, participants will be randomly assigned to one of the following four groups for 44 weeks of treatment:
Each participant will receive three inhalers with their assigned medication. One inhaler will be used twice daily throughout the study. The other two inhalers will be used consecutively on an as-needed-basis as rescue medication. Study visits will occur at Weeks 8, 16, 24, 32, 40, and 48. A physical examination, blood collection, and lung function and airway pressure testing will occur at selected visits. Questionnaires to assess quality of life and asthma control will also be completed. A methacholine challenge test will be completed at some study visits. This test artificially triggers an asthma attack to determine the severity of an individual's asthma. Throughout the study, participants will record asthma symptoms and rescue medication usage in a daily diary.
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
History of asthma symptoms that are adequately controlled in the 4 weeks prior to study entry, and meets at least one of the following criteria:
Participants will be eligible for the 44 weeks of treatment if, after the 4-week screening period, their asthma remains controlled, and they demonstrate at least 80% predicted pre-bronchodilator FEV1. Participants must meet ALL of the criteria stated below during the 8-week screening period to continue in the study:
Meets the definition of acceptable asthma control, which is NOT having one or more of the following during ANY 2-week period:
On average, on more than 2 days per week, experiences one or more of the following:
Exclusion Criteria:
Corticosteroid treatment for any condition prior to study entry within the following defined timepoints:
United States, Arizona | |
University of Arizona College of Medicine | Recruiting |
Tucson, Arizona, United States, 85724 | |
Contact: Fernando D. Martinez, MD 520-626-6387 fernando@resp-sci.arizona.edu | |
Contact: Wayne Morgan, MD 520-626-7780 wmorgan@resp-sci.arizona.edu | |
Principal Investigator: Fernando D. Martinez, MD | |
United States, California | |
Kaiser Permanente Medical Center | Recruiting |
San Diego, California, United States, 92111 | |
Contact: Robert S. Zeiger, MD, PhD 858-573-5408 robert.s.zeiger@kp.org | |
Contact: Gregory P. Heldt, MD 619-543-3790 gheldt@ucsd.edu | |
Principal Investigator: Robert S. Zeiger, MD, PhD | |
Los Angeles, Kaiser Permanente Allergy Department | Recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Michael S. Kaplan, MD 323-783-4642 michael.s.kaplan@kp.org | |
Sub-Investigator: Michael S. Kaplan, MD | |
United States, Colorado | |
National Jewish Medical and Research Center | Recruiting |
Denver, Colorado, United States, 80206 | |
Contact: Stanley J. Szefler, MD, PhD 303-398-1193 szeflers@njc.org | |
Contact: Gary Larsen, MD 303-398-1617 larseng@njc.org | |
Principal Investigator: Stanley J. Szefler, MD, PhD | |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Robert C. Strunk, MD 341-454-2284 strunk@kids.wustl.edu | |
Contact: Leonard Bacharier, MD 314-454-4233 bacharier_l@kids.wustl.edu | |
Principal Investigator: Robert C. Strunk, MD | |
United States, Wisconsin | |
University of Wisconsin - Madison | Recruiting |
Madison, Wisconsin, United States, 53792-3244 | |
Contact: Robert F. Lemanske, Jr., MD 608-265-2206 rfl@medicine.wisc.edu | |
Contact: Christine A. Sorkness, PharmD 608-263-2866 sorkness@facstaff.wisc.edu | |
Principal Investigator: Robert F. Lemanske, Jr., MD |
Principal Investigator: | David T. Mauger, PhD | Penn State College of Medicine |
Principal Investigator: | Stanley J. Szefler, MD, PhD | National Jewish Health |
Principal Investigator: | Robert F. Lemanske, Jr., MD | University of Wisconsin, Madison |
Principal Investigator: | Robert S. Zeiger, MD, PhD | Kaiser Permanente Medical Center |
Principal Investigator: | Robert C. Strunk, MD | Washington University School of Medicine |
Principal Investigator: | Fernando D. Martinez, MD | University of Arizona College of Medicine |
Study Chair: | Lynn M. Taussig, MD | University of Denver |
Responsible Party: | Pennsylvania State University, College of Medicine ( Vernon M. Chinchilli, PhD ) |
Study ID Numbers: | 445, 5U10HL064313, 5U10HL064288, 5U10HL064305, 5U10HL064295, 5U10HL064287, 5U10HL064307 |
Study First Received: | October 30, 2006 |
Last Updated: | February 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00394329 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Procaterol Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Hormone Antagonists Albuterol Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Asthma Beclomethasone |
Hormones Glucocorticoids Adrenergic Agonists Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchial Diseases Adrenergic Agents Albuterol Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Beclomethasone Reproductive Control Agents Hormones Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive |
Respiratory Tract Diseases Tocolytic Agents Therapeutic Uses Immune System Diseases Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |