NCT00623688

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

4.2 years

First QC Date

February 6, 2008

Last Update Submit

January 13, 2015

Conditions

Status Asthmaticus

Keywords

Metered Dose InhalersNebulizersRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Change in Clinical Asthma Severity score over time

    72 hours

Secondary Outcomes (3)

  • Time to discharge

    Total time in the hospital

  • Time to when are able to go 4 hours between albuterol treatments

    Time in hospital

  • Cost of delivering albuterol by MDI versus nebulizer

    Time in hospital

Study Arms (2)

1

EXPERIMENTAL

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)

2

ACTIVE COMPARATOR

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

Interventions

Metered Dose Inhaler & Optichamber Advantage Valve Holding Chamber (VHC)DEVICE

Albuterol is delivered by metered dose inhaler with valved holding chamber. For children less than 6 years of age, a mask is also used.

1
Airlife Sidestream High Efficiency NebulizerDEVICE

Albuterol is delivered as a mist mixed with normal saline using a nebulizer machine and face mask or mouth piece.

2

Eligibility Criteria

Age12 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308-1062, United States

Location

Related Publications (7)

  • 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. doi: 10.1001/archpedi.1995.02170140083015.

    PMID: 7849885BACKGROUND

  • 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.

    PMID: 3758239BACKGROUND

  • 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. doi: 10.1016/s0022-3476(05)81710-x.

    PMID: 8345434BACKGROUND

  • Lin YZ, Hsieh KH. Metered dose inhaler and nebuliser in acute asthma. Arch Dis Child. 1995 Mar;72(3):214-8. doi: 10.1136/adc.72.3.214.

    PMID: 7741566BACKGROUND

  • 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. doi: 10.1016/0895-4356(96)00027-3.

    PMID: 8699199BACKGROUND

  • 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. doi: 10.5694/j.1326-5377.1989.tb101224.x.

    PMID: 2677624BACKGROUND

  • 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. doi: 10.1002/(sici)1099-0496(200004)29:43.0.co;2-s.

    PMID: 10738013BACKGROUND

MeSH Terms

Conditions

Status Asthmaticus

Interventions

Metered Dose Inhalers

Condition Hierarchy (Ancestors)

AsthmaBronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Nebulizers and VaporizersEquipment and Supplies

Study Officials

  • Kimberly A Spoonhower, M.D.

    Akron Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 26, 2008

Study Start

February 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

US(1)