Effectiveness and Cost Study Comparing Two Ways to Deliver Albuterol for the Treatment of Asthma in the Hospital
|ClinicalTrials.gov Identifier: NCT00623688|
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : January 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Status Asthmaticus||Device: Metered Dose Inhaler & Optichamber Advantage Valve Holding Chamber (VHC) Device: Airlife Sidestream High Efficiency Nebulizer||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effectiveness and Costs of Albuterol Delivered by MDI With Spacer Versus Nebulizer in Children Hospitalized With Moderate and Severe Asthma Exacerbations|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
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.
- Change in Clinical Asthma Severity score over time [ Time Frame: 72 hours ]
- Time to discharge [ Time Frame: Total time in the hospital ]
- Time to when are able to go 4 hours between albuterol treatments [ Time Frame: Time in hospital ]
- Cost of delivering albuterol by MDI versus nebulizer [ Time Frame: Time in hospital ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623688
|United States, Ohio|
|Akron Children's Hospital|
|Akron, Ohio, United States, 44308-1062|
|Principal Investigator:||Kimberly A Spoonhower, M.D.||Akron Children's Hospital|