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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: | NCT00394329 |
Purpose
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 |
|---|---|---|
|
Asthma |
Drug: Beclomethasone dipropionate Drug: Albuterol sulfate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Childhood Asthma Research and Education (CARE) Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA) |
| Enrollment: | 280 |
| Study Start Date: | November 2006 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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
|
Drug: Beclomethasone dipropionate
Beclomethasone diproprionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Other Name: QVAR®
Drug: Beclomethasone dipropionate
Beclomethasone diproprionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed
Other Name: QVAR®
Drug: Albuterol sulfate
Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Other Name: ProAir®
|
|
Active Comparator: B
Beclomethasone diproprionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
|
Drug: Beclomethasone dipropionate
Beclomethasone diproprionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid
Other Name: QVAR®
Drug: Albuterol sulfate
Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Other Name: ProAir®
|
|
Experimental: C
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
Other Name: QVAR®
Drug: Albuterol sulfate
Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Other Name: ProAir®
|
|
Placebo Comparator: D
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
Other Name: ProAir®
|
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.
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 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:
NOTE: In January 2008, the Data and Safety Monitoring Board (DSMB) approved changes in the TREXA eligibility criteria, by which neither FEV1 reversibility ≥ 12% nor a participant's methacholine PC20 ≤ 12.5 mg/ml were required for randomization.
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 | |
| Los Angeles, Kaiser Permanente Allergy Department | |
| Los Angeles, California, United States, 90027 | |
| 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, 53792-3244 | |
| 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: | NCT00394329 History of Changes |
| Other Study ID Numbers: | 445, 5U10HL064313, 5U10HL064288, 5U10HL064305, 5U10HL064295, 5U10HL064287, 5U10HL064307 |
| Study First Received: | October 30, 2006 |
| Last Updated: | December 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Albuterol Procaterol Beclomethasone 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 Anti-Inflammatory Agents Glucocorticoids |