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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: | NCT00471809 |
The MARS trial is a randomized, double-blind, parallel group study that compares the capacity of azithromycin or montelukast to placebo as effective adjunctive therapy that allows reduction of inhaled corticosteroids in children ages 6 to 17 years with moderate to severe persistent asthma. The primary null hypothesis is that in children with moderate-to-severe persistent asthma, a macrolide antibiotic (azithromycin) or a leukotriene receptor antagonist (montelukast) will provide a steroid-sparing effect when compared to placebo as the dose of inhaled corticosteroid is reduced. This will be tested following achievement of control of symptoms with moderate to high-dose inhaled corticosteroid in combination with a long-acting bronchodilator agonist. Use of these doses for the inhaled corticosteroid will be based on NHLBI step-up guidelines to achieve asthma control.
Condition | Intervention | Phase |
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Asthma |
Drug: Budesonide + Salmeterol + Azithromycin Drug: Budesonide + Salmeterol + Montelukast Drug: Budesonide + Salmeterol + Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS) |
Estimated Enrollment: | 210 |
Study Start Date: | March 2006 |
Study Completion Date: | March 2007 |
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At Enrollment (V0):
Moderate to severe persistent asthma:
Patients will be identified in the following general categories. The general principle is that patients will be uncontrolled on a relatively low dose of ICS that can be stepped-up, or controlled on a moderate or high dose of ICS that can be stepped-down.
i) On low dose ICS with or without salmeterol and uncontrolled. This patient will be treated with budesonide and salmeterol to determine eligibility criteria. If the addition of salmeterol results in control of symptoms, the patient would be excluded from MARS. If control was not established on low dose budesonide and salmeterol, the dose of budesonide would be increased and entry criteria evaluated based on the algorithm in Figure 1.
ii) On a dose of ICS equivalent to budesonide at 400 mcg per day with or without any other medication and uncontrolled. This patient will be treated with budesonide and salmeterol to determine eligibility criteria.
iii) On a dose of ICS equivalent to budesonide at 800 mcg per day with or without any other medication and controlled.
iv) On a dose of ICS equivalent to budesonide at 1600 mcg per day with or without any other medication and uncontrolled but not requiring prednisone acutely. These patients will be followed to see if they become well controlled with increased adherence or more careful monitoring of symptoms.
Examples are given for Advair as this drug is a commonly used form of ICS and LABA:
i) Patients on Advair 100/50 bid and inadequately controlled ii) Patients on Advair 250/50 bid and inadequately controlled iii) Patients on Advair 250/50 bid and well controlled for greater than 3 months and being considered for stepping-down to Advair 100/50 iv) Patients well controlled on Advair 100/50 bid + either montelukast or theophylline for greater than 3 months and being considered for stepping-down to Advair 100/50 bid alone v) Patients on Advair 500/50 bid and well controlled for greater than 3 months and being considered for stepping-down to Advair 250/50 vi) Patients well controlled on Advair 250/50 bid + either montelukast or theophylline for greater than 3 months and being considered for stepping-down to Advair 250/50 bid alone
Demonstrate a bronchodilator response with an improvement in FEV1 of at least 12% or airway responsiveness to methacholine with a PC20 less than 12.5 mg/ml.
Exclusion Criteria:
At Enrollment (V0):
At Randomization (V2):
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 | |
Los Angeles, Kaiser Permanente Allergy Department | |
Los Angeles, California, United States, 90027 | |
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, 53792-3244 |
Principal Investigator: | Vernon M. Chinchilli, 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 |
Study ID Numbers: | 447, 5U10HL064313, 5U10HL064288, 5U10HL064305, 5U10HL064295, 5U10HL064287, 5U10HL064307 |
Study First Received: | May 8, 2007 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00471809 |
Health Authority: | United States: Food and Drug Administration |
Montelukast Hypersensitivity Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases Azithromycin |
Lung Diseases Budesonide Hypersensitivity, Immediate Asthma Leukotriene Antagonists Respiratory Hypersensitivity |
Anti-Inflammatory Agents Anti-Infective Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists Bronchial Diseases Immune System Diseases Hormone Antagonists Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Hormones Glucocorticoids Adrenergic Agonists Pharmacologic Actions Anti-Bacterial Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |