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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by (Responsible Party): | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00395304 |
Purpose
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 compares 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 |
|---|---|---|
|
Asthma |
Drug: fluticasone propionate + montelukast Drug: fluticasone propionate Drug: fluticasone propionate + salmeterol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER) |
| Enrollment: | 182 |
| Study Start Date: | March 2007 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Crossover Sequences
Sequence 1: fluticasone propionate + montelukast, followed by fluticasone propionate, followed by fluticasone propionate + salmeterol Sequence 2: fluticasone propionate, followed by fluticasone + salmeterol, followed by fluticasone propionate + montelukast Sequence 3: fluticasone propionate + salmeterol, followed by fluticasone propionate + montelukast, followed by fluticasone propionate Sequence 4: fluticasone propionate + montelukast, followed by fluticasone propionate + salmeterol, followed by fluticasone propionate Sequence 5: fluticasone propionate + salmeterol, followed by fluticasone propionate, followed by fluticasone propionate + montelukast Sequence 6: fluticasone propionate, followed by fluticasone propionate + montelukast, followed by fluticasone propionate + salmeterol |
Drug: fluticasone propionate + montelukast
Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
Other Name: Flovent Diskus® + Singulair®
Drug: fluticasone propionate
Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
Other Name: Flovent Diskus®
Drug: fluticasone propionate + salmeterol
Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
Other Name: Advair Diskus®
|
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 began with an 8-week screening period during which participants were monitored while they used an inhaler with a low dose of ICS medication. During this time, participants also attended one or two study visits. At each visit, participants underwent a physical examination, exhaled nitric oxide analysis, and lung function and airway pressure testing. After enrollment criteria were met, participants underwent these same evaluations again, and they completed questionnaires to assess asthma control, quality of life, and home environmental factors. Blood was collected and a methacholine challenge test was completed, which artificially triggers an asthma attack to determine the severity of an individual's asthma. Participants then were randomly assigned to one of six treatment sequences, each of which includes the following three regimens in a different order:
Each treatment period lasted 16 weeks, with study visits occurring weekly. A physical examination, blood collection, lung function and airway pressure testing, a methacholine challenge test, and questionnaires occurred at selected visits. Throughout the study, participants recorded asthma symptoms, peak expiratory flow rates, and rescue medication usage in a daily diary. The entire length of the study did not exceed 56 weeks.
Eligibility| 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:
Contacts and Locations| 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 |
| 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 |
More Information
| Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00395304 History of Changes |
| Other Study ID Numbers: | 444, 5U10HL064313, 5U10HL064288, 5U10HL064305, 5U10HL064295, 5U10HL064287, 5U10HL064307 |
| Study First Received: | October 31, 2006 |
| Results First Received: | May 17, 2010 |
| Last Updated: | April 30, 2012 |
| Health Authority: | United States: Federal Government |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Salmeterol Fluticasone Montelukast Fluticasone, salmeterol drug combination Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |