NCT00528814

Brief Summary

Asthma is a common, serious illness among children in the United States. Improving hand cleanliness and hygiene may prevent the spread of viruses that can cause asthma exacerbations. This study will evaluate the effectiveness of a school-based hand sanitizer program at reducing the frequency of exacerbations in children with asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
527

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable asthma

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

First Submitted

Initial submission to the registry

September 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

September 10, 2007

Last Update Submit

November 22, 2017

Conditions

Asthma

Keywords

Hand SanitizerRespiratory Infection

Outcome Measures

Primary Outcomes (1)

  • Asthma exacerbations

    Measured at Years 1 and 2

Study Arms (2)

Two Step Hand-Hygiene

EXPERIMENTAL

Hand washing plus hand sanitizer

Other: Active Hand Sanitizer

Usual Care Hand Hygiene

NO INTERVENTION

Interventions

Active Hand SanitizerOTHER

Active Hand Sanitizer

Also known as: Purell
Two Step Hand-Hygiene

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed with asthma
  • Enrolled in a participating elementary school

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham, Lung Health Center

Birmingham, Alabama, 35233, United States

Location

Related Publications (2)

  • Gerald LB, Gerald JK, Zhang B, McClure LA, Bailey WC, Harrington KF. Can a school-based hand hygiene program reduce asthma exacerbations among elementary school children? J Allergy Clin Immunol. 2012 Dec;130(6):1317-24. doi: 10.1016/j.jaci.2012.08.031. Epub 2012 Oct 12.

    PMID: 23069487DERIVED

  • Gerald LB, Gerald JK, McClure LA, Harrington K, Erwin S, Bailey WC. Redesigning a large school-based clinical trial in response to changes in community practice. Clin Trials. 2011 Jun;8(3):311-9. doi: 10.1177/1740774511403513.

    PMID: 21730079DERIVED

MeSH Terms

Conditions

AsthmaRespiratory Tract Infections

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesInfections

Study Officials

  • William Bailey, MD

    University of Alabama at Birmingham, Lung Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 12, 2007

Study Start

January 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2012

Last Updated

November 27, 2017

Record last verified: 2017-11

Locations

US(1)