Effectiveness and Cost Study Comparing Two Ways to Deliver Albuterol for the Treatment of Asthma in the Hospital
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|