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Sponsored by: |
University of New Mexico |
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Information provided by: | University of New Mexico |
ClinicalTrials.gov Identifier: | NCT00662779 |
It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen.
Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.
Condition | Intervention | Phase |
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Exercise-Induced Bronchospasm |
Drug: arformoterol Drug: formoterol Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Bronchoprotective Effect of Arformoterol in Children With Exercise Induced Bronchospasm |
Estimated Enrollment: | 15 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder
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Drug: arformoterol
15 mcg arformoterol nebulizer
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2: Active Comparator
1 inhalation of formoterol fumarate inhalation powder (12 mcg/inhalation) + 2 ml of normal saline nebulizer
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Drug: formoterol
Formoterol 12 mcg/inhalation, dry powder inhaler
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3: Placebo Comparator
1 inhalation of placebo inhalation powder + 2 ml of normal saline nebulizer
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Drug: placebo
placebo dry powder capsules ( lactose) and placebo normal saline for nebulization
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This study is a randomized, double-blind, double-dummy, crossover clinical trial which will consist of 5 study visits and will last up to 3 weeks.
Fifteen children 12-17 years of age with asthma and EIB, regardless of current asthma therapy will be eligible for this trial.
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hengameh Raissy, Pharm.D. | 505-272-5484 | hheidarian-raissy@salud.unm.edu |
Contact: William Kelly, Pharm.D. | 505-272-3658 | Hwkelly@salud.unm.edu |
United States, New Mexico | |
University of New Mexico | Recruiting |
Albuquerque, New Mexico, United States, 87107 | |
Contact: Fran Kelly, BS 505-272-9889 FMKelly@salud.unm.edu | |
Contact: Hengameh Raissy, Pharm.D. 505-272-5484 hheidarian-raissy@salud.unm.edu | |
Principal Investigator: Hengameh Raissy, Pharm.D. | |
Sub-Investigator: William Kelly, Pharm.D. | |
Sub-Investigator: Michelle Harkins, MD | |
Sub-Investigator: Lea Davies, MD |
Principal Investigator: | Hengameh Raissy, Pharm.D. | University of New Mexico- Pediatric department |
Responsible Party: | School of Medicine, University of New Mexico ( Hengameh H. Raissy, Pharm.D. ) |
Study ID Numbers: | ASRC948, 5-MO1-RR-00997 |
Study First Received: | April 16, 2008 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00662779 |
Health Authority: | United States: Food and Drug Administration |
asthma exercise induced bronchospasm prevention EIB children |
Asthma, Exercise-Induced Spasm Hypersensitivity Bronchial Spasm Respiratory Tract Diseases |
Hypersensitivity, Immediate Formoterol Asthma Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Immune System Diseases Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Anti-Asthmatic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |