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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00623688
First received: February 6, 2008
Last updated: June 24, 2014
Last verified: June 2014
  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:


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 ]

Enrollment: 11
Study Start Date: February 2008
Study Completion Date: April 2012
Primary Completion Date: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 24, 2014
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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Albuterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on October 20, 2014