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Sponsored by: |
Akron Children's Hospital |
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Information provided by: | Akron Children's Hospital |
ClinicalTrials.gov Identifier: | NCT00623688 |
This study will be conducted as a randomized, double blinded, controlled trial. The control group will receive albuterol delivered by a nebulizer along with placebo treatments delivered by a metered dose inhaler (MDI) with a spacer +/- mask. The experimental group will receive albuterol delivered by MDI with spacer +/- mask along with placebo treatments given by a nebulizer. Parents, participants, study personnel, nursing staff, and respiratory therapists will not know the treatment assignments of participants. The primary outcome will be changes over time in an asthma severity score, the Clinical Asthma Score (CAS) (Parkin et al. 1996). The secondary outcomes will be total number of albuterol treatments received in the hospital, time it take to give treatments, time till subjects' albuterol treatments are given at four hour intervals, and the costs of the two types of treatments. The study hypothesis is that albuterol delivered by metered dose inhaler with spacer is non-inferior to albuterol delivered by nebulizer in the treatment of children hospitalized with moderate to severe asthma exacerbations.
Condition | Intervention |
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Status Asthmaticus |
Device: Metered Dose Inhaler & Optichamber Advantage VHC Device: Airlife Sidestream High Efficiency Nebulizer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effectiveness and Costs of Albuterol Delivered by MDI With Spacer Versus Nebulizer in Children Hospitalized With Moderate and Severe Asthma Exacerbations |
Estimated Enrollment: | 50 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Subjects receive active medication (albuterol) delivered by metered dose inhaler and placebo (no medicine) by nebulizer.
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Device: Metered Dose Inhaler & Optichamber Advantage VHC
Albuterol is delivered by metered dose inhaler with valved holding chamber. For children less than 6 years of age, a mask is also used.
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2: Active Comparator
Subjects receive active medication (albuterol) delivered by nebulizer and placebo (no medicine) delivered by metered dose inhaler.
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Device: Airlife Sidestream High Efficiency Nebulizer
Albuterol is delivered as a mist mixed with normal saline using a nebulizer machine and face mask or mouth piece.
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Ages Eligible for Study: | 12 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kimberly A Spoonhower, M.D. | 330-543-8885 | KSpoonhower@chmca.org |
Contact: Greg Omlor, M.D. | 330-543-8885 | gomlor@chmca.org |
United States, Ohio | |
Akron Children's Hospital | Recruiting |
Akron, Ohio, United States, 44308-1062 | |
Principal Investigator: Kimberly A Spoonhower, M.D. | |
Sub-Investigator: Greg Omlor, M.D. | |
Sub-Investigator: Michelle Stevenson, M.D. |
Principal Investigator: | Kimberly A Spoonhower, M.D. | Akron Children's Hospital |
Responsible Party: | Akron Children's Hospital ( Kimberly Spoonhower, M.D./Pediatric Pulmonologist ) |
Study ID Numbers: | 070908 |
Study First Received: | February 6, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00623688 |
Health Authority: | United States: Institutional Review Board |
Metered Dose Inhalers Nebulizers Randomized Controlled Trial |
Hypersensitivity Respiratory Tract Diseases Status Asthmaticus Albuterol |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Bronchial Diseases Immune System Diseases Adrenergic beta-Agonists Physiological Effects of Drugs Anti-Asthmatic Agents |
Reproductive Control Agents Adrenergic Agonists Pharmacologic Actions Tocolytic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |