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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: | NCT00395304 |
Asthma is a common, serious illness among children in the United States. While a low dose of inhaled corticosteroids (ICS) may effectively control symptoms, some children may require additional medications to maintain adequate asthma control. This study will compare the effectiveness of a higher dose of ICS, ICS combined with a long-acting beta-agonist (LABA) medication, and ICS combined with a leukotriene receptor antagonist (LTRA) medication at reducing the impact and severity of asthma exacerbations that occur in children with mild to moderate persistent asthma.
Condition | Intervention | Phase |
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Asthma |
Drug: Fluticasone propionate Drug: Montelukast Drug: Fluticasone propionate/salmeterol |
Phase III |
Study Type: | Interventional |
Study Design: | Active Control, Crossover Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized, Safety/Efficacy Study, Treatment |
Official Title: | Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER) |
Estimated Enrollment: | 180 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) + montelukast 5 or 10 mg qd (Singulair®, Merck)
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Drug: Fluticasone propionate
Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline)
Drug: Montelukast
Montelukast 5 or 10 mg qd (Singulair®, Merck)
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2: Active Comparator
Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
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Drug: Fluticasone propionate
Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
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3: Active Comparator
Dry-powder inhaler fluticasone/salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
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Drug: Fluticasone propionate/salmeterol
Dry-powder inhaler fluticasone/salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
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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. Low doses of ICS are commonly prescribed to prevent symptoms and keep asthma under control. While this is usually sufficient to prevent asthma attacks, some children do not respond well to low dose ICS alone. For these children, their asthma symptoms may be more effectively controlled by either receiving a higher dose of ICS or receiving LABA or LTRA medications in combination with a low dose of ICS. Both LABA and LTRA medications are used to help control moderate to severe asthma. The purpose of this study is to compare the effectiveness of a high dose of ICS versus a low dose of ICS plus either LABA or LTRA medication at improving asthma control and reducing the severity of symptoms that occur in children with mild to moderate persistent asthma.
This study will begin with an 8-week screening period during which participants will be monitored while they use an inhaler with a low dose of ICS medication. During this time, participants will also attend one or two study visits. At each visit, participants will undergo a physical examination, exhaled nitric oxide analysis, and lung function and airway pressure testing. Once enrollment criteria are met, participants will undergo these same evaluations again, and they will complete questionnaires to assess asthma control, quality of life, and home environmental factors. Blood will be collected and a methacholine challenge test will be completed, which will artificially trigger an asthma attack to determine the severity of an individual's asthma. Participants will then be randomly assigned to one of six treatment sequences, each of which will include the following three regimens in a different order:
Each treatment period will last 16 weeks, with study visits occurring weekly. A physical examination, blood collection, lung function and airway pressure testing, a methacholine challenge test, and questionnaires will occur at selected visits. Throughout the study, participants will record asthma symptoms, peak expiratory flow rates, and rescue medication usage in a daily diary. The entire length of the study will not exceed 56 weeks.
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
History of asthma symptoms (e.g., cough, wheezing, shortness of breath) and meets at least one of the following criteria:
Prior to being randomly assigned to a treatment group, participants must meet the following criteria to remain in the study:
Lack of acceptable asthma control during the 8-week screening period as defined by the following criteria:
1) On average, on more than 2 days per week, one or all 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 | |
Tucson, Arizona, United States, 85724 | |
United States, California | |
Kaiser Permanente Medical Center | |
San Diego, California, United States, 92111 | |
United States, Colorado | |
National Jewish Medical and Research Center | |
Denver, Colorado, United States, 80206 | |
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 | |
United States, Wisconsin | |
University of Wisconsin - Madison | |
Madison, Wisconsin, United States, 53792 |
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 |
Study Chair: | Lynn M. Taussig, MD | University of Denver |
Principal Investigator: | Robert C. Strunk, MD | Washington University School of Medicine |
Principal Investigator: | Fernando D. Martinez, MD | University of Arizona College of Medicine |
Principal Investigator: | Robert S. Zeiger, MD, PhD | Kaiser Permanente Medical Center |
Responsible Party: | Pennsylvania State University, College of Medicine ( Vernon M. Chinchilli, PhD ) |
Study ID Numbers: | 444, 5U10HL064287, 5U10HL064288, 5U10HL064295, 5U10HL064305, 5U10HL064307, 5U10HL064313 |
Study First Received: | October 31, 2006 |
Last Updated: | February 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00395304 History of Changes |
Health Authority: | United States: Federal Government |
Anti-Inflammatory Agents Neurotransmitter Agents Salmeterol Bronchial Diseases Adrenergic Agents Adrenergic beta-Agonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Asthma Anti-Allergic Agents Hormones |
Adrenergic Agonists Leukotriene Antagonists Montelukast Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Fluticasone Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Adrenergic Agonists Leukotriene Antagonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses |
Fluticasone Dermatologic Agents Salmeterol Adrenergic beta-Agonists Immune System Diseases Asthma Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Montelukast Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents |