Effectiveness and Cost Study Comparing Two Ways to Deliver Albuterol for the Treatment of Asthma in the Hospital

Completed · Not applicable

Conditions studied: Status Asthmaticus

In brief

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.

Key facts

Study ID

NCT00623688

Run by

Akron Children's Hospital

People needed

11

Starts

2008-02-01

Expected to finish

2012-04-01

Last updated by the study team

2015-01-14

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Akron Children's Hospital — Akron, Ohio, United States

Full record on ClinicalTrials.gov

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