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

Sponsor:	Akron Children's Hospital
Information provided by (Responsible Party):	Akron Children's Hospital
ClinicalTrials.gov Identifier:	NCT00623688

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 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 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:	May 2012
Estimated Primary Completion Date:	May 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 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 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:

Chou KJ, Cunningham SJ, Crain EF. Metered-dose inhalers with spacers vs nebulizers for pediatric asthma. Arch Pediatr Adolesc Med. 1995 Feb;149(2):201-5. Erratum in: Arch Pediatr Adolesc Med 1995 May;149(5):545.

Fuglsang G, Pedersen S. Comparison of Nebuhaler and nebulizer treatment of acute severe asthma in children. Eur J Respir Dis. 1986 Aug;69(2):109-13.

Kerem E, Levison H, Schuh S, O'Brodovich H, Reisman J, Bentur L, Canny GJ. Efficacy of albuterol administered by nebulizer versus spacer device in children with acute asthma. J Pediatr. 1993 Aug;123(2):313-7.

Lin YZ, Hsieh KH. Metered dose inhaler and nebuliser in acute asthma. Arch Dis Child. 1995 Mar;72(3):214-8.

Parkin PC, Macarthur C, Saunders NR, Diamond SA, Winders PM. Development of a clinical asthma score for use in hospitalized children between 1 and 5 years of age. J Clin Epidemiol. 1996 Aug;49(8):821-5.

Pendergast J, Hopkins J, Timms B, Van Asperen PP. Comparative efficacy of terbutaline administered by Nebuhaler and by nebulizer in young children with acute asthma. Med J Aust. 1989 Oct 2;151(7):406-8.

Rubilar L, Castro-Rodriguez JA, Girardi G. Randomized trial of salbutamol via metered-dose inhaler with spacer versus nebulizer for acute wheezing in children less than 2 years of age. Pediatr Pulmonol. 2000 Apr;29(4):264-9.

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:	October 31, 2011
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 February 09, 2012