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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: | NCT00000575 |
The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
Condition | Intervention | Phase |
---|---|---|
Asthma Lung Diseases |
Drug: Placebo Drug: Nedocromil Drug: Budesonide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Childhood Asthma Management Program |
Enrollment: | 1041 |
Study Start Date: | September 1991 |
Estimated Study Completion Date: | June 2011 |
Primary Completion Date: | October 1999 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 Budesonide: Active Comparator
Budesonide (Pulmicort), two 100 Og puffs bid + two Og puffs albuterol (Ventolin) prn
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Drug: Budesonide
Two 100 Og puffs bid + two 90 Og puffs albuterol prn.
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2 Nedocromil: Active Comparator
Nedocromil (Tilade), four 2 mg puffs bid + two 90 Og puffs albuterol prn
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Drug: Nedocromil
Four 2 mg puffs bid + two 90 Og puffs albuterol prn
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3 Placebo: Placebo Comparator
Two 100 Og puffs budesonide placebo bid + two 90 Og puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 Og puffs albuterol prn.
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Drug: Placebo
Two 100 Og puffs budesonide placebo bid + two 90 Og puffs albuterol prn OR four 2 mg puffs nedocromil placebo bid + two 90 Og puffs albuterol prn.
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Ages Eligible for Study: | 5 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Principal Investigator: | N. F. Adkinson, MD | Johns Hopkins University |
Principal Investigator: | Anne Fuhlbrigge, MD, MS | Brigham and Women's Hospital |
Principal Investigator: | H. W. Kelly, PharmD | University of New Mexico |
Principal Investigator: | Padmaja Subbarao, MD, MSc | The Hospital for Sick Children |
Principal Investigator: | Paul Williams, MD | Asthma, Inc. |
Principal Investigator: | Robert Strunk, MD | Washington University School of Medicine |
Principal Investigator: | Stanley Szefler, MD | National Jewish Health |
Principal Investigator: | James Tonascia, PhD | Johns Hopkins University |
Principal Investigator: | Robert Zeiger, MD, PhD | University of California, San Diego |
Responsible Party: | NHLBI ( Virginia Taggart, Project Officer ) |
Study ID Numbers: | 213 |
Study First Received: | October 27, 1999 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00000575 History of Changes |
Health Authority: | United States: Federal Government |
Anti-Inflammatory Agents Bronchial Diseases Hormone Antagonists Albuterol Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Asthma Anti-Allergic Agents Hormones |
Glucocorticoids Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Nedocromil Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Asthma Anti-Allergic Agents Hormones Glucocorticoids |
Pharmacologic Actions Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Nedocromil Bronchodilator Agents Respiratory Hypersensitivity |