Effectiveness and Cost Study Comparing Two Ways to Deliver Albuterol for the Treatment of Asthma in the Hospital
This study is ongoing, but not recruiting participants.
Sponsor:
Akron Children's Hospital
Information provided by (Responsible Party):
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00623688
First received: February 6, 2008
Last updated: December 13, 2012
Last verified: December 2012
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Purpose
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 |
|---|---|
|
Status Asthmaticus |
Device: Metered Dose Inhaler & Optichamber Advantage Valve Holding Chamber (VHC) Device: Airlife Sidestream High Efficiency Nebulizer |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effectiveness and Costs of Albuterol Delivered by MDI With Spacer Versus Nebulizer in Children Hospitalized With Moderate and Severe Asthma Exacerbations |
Resource links provided by NLM:
MedlinePlus related topics:
Asthma
Drug Information available for:
Albuterol
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
Levalbuterol tartrate
U.S. FDA Resources
Further study details as provided by Akron Children's Hospital:
Primary Outcome Measures:
- Change in Clinical Asthma Severity score over time [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to discharge [ Time Frame: Total time in the hospital ] [ Designated as safety issue: No ]
- Time to when are able to go 4 hours between albuterol treatments [ Time Frame: Time in hospital ] [ Designated as safety issue: No ]
- Cost of delivering albuterol by MDI versus nebulizer [ Time Frame: Time in hospital ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Subjects receive active medication (albuterol) delivered by a Proair metered dose inhaler used with an Opti-chamber and placebo (normal saline solution) by nebulizer aerosol.
|
Device: Metered Dose Inhaler & Optichamber Advantage Valve Holding Chamber (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.
|
|
Active Comparator: 2
Subjects receive active medication (albuterol) delivered by nebulizer and placebo (no medicine) delivered by a demonstrator Placebo metered dose inhaler demonstrator.
|
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 12 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Children 1 to 18 years of age with a known history of asthma being admitted to Akron Children's Hospital general medical floor for the treatment of moderate to severe asthma exacerbations
Exclusion Criteria:
- Children who have a concurrent pneumonia or bronchiolitis (diagnosed clinically or by chest x-ray)
- Have a diagnosis of chronic lung disease (ex. cystic fibrosis, bronchopulmonary dysplasia, chronic aspiration)
- Have cyanotic congenital heart disease, a congenital anomaly of the respiratory tract, or who are tracheostomy or ventilator dependent.
- Children who are determined by the Emergency Department (ED) or general pediatrics service to need ICU level care on admission will also be excluded.
- Children will also be excluded if their legal guardian does not speak English as all consent forms will be written and reviewed with guardians in English.
- Children will also be excluded if their legal guardians disagree on consent to participate, or if a child 9 years or older and their legal guardians disagree on study participation.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623688
Locations
| United States, Ohio | |
| Akron Children's Hospital | |
| Akron, Ohio, United States, 44308-1062 | |
Sponsors and Collaborators
Akron Children's Hospital
Investigators
| Principal Investigator: | Kimberly A Spoonhower, M.D. | Akron Children's Hospital |
More Information
Publications:
| Responsible Party: | Akron Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00623688 History of Changes |
| Other Study ID Numbers: | 070908 |
| Study First Received: | February 6, 2008 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Akron Children's Hospital:
|
Metered Dose Inhalers Nebulizers Randomized Controlled Trial |
Additional relevant MeSH terms:
|
Status Asthmaticus Asthma Bronchial Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Albuterol 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 |
ClinicalTrials.gov processed this record on May 19, 2013