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Effectiveness of a School-Based Hand Sanitizer Program on Reducing Asthma Exacerbations

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ClinicalTrials.gov Identifier: NCT00528814
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : November 27, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Asthma Other: Active Hand Sanitizer

Detailed Description:

In the United States, almost 9 million children have been diagnosed with asthma. It is a leading cause of hospitalizations and school absenteeism among children. Asthma symptoms are often seasonal, with the greatest number of exacerbations occurring in autumn and the fewest in mid-summer. Elementary school children are the most vulnerable to these seasonal changes, and many children experience an increase in exacerbations at the beginning of the school year. Recent research suggests that this seasonal peak in exacerbations is primarily caused by viral respiratory tract infections that are spread among children in school. Regular handwashing has been widely recognized as the most effective way to stop the spread of viruses and infectious illnesses. However, effective handwashing methods among school-age children can be inconsistent. Time constraints, a frequent lack of soap and towels, inconveniently located sinks, and water-saving faucets are all barriers to thorough handwashing. Improving hand hygiene through the use of antimicrobial rinse-free hand sanitizers in school classrooms may be a simple and effective way to reduce the risk of transmitting viruses that can cause asthma exacerbations. The purpose of this study is to evaluate the effectiveness of a school-based hand sanitizer program at decreasing exacerbations in children with asthma.

This study will enroll children with asthma who are attending one of the 32 participating schools. Each school will be randomly assigned to either use their usual hand hygiene practices in Year 1, followed by a two-step hand hygiene program including hand washing plus hand sanitizer in Year 2, or vice versa. Each participant will log in to an Internet-based data collection system on a daily basis to document their asthma symptoms and peak flow meter readings. Teachers will also log in daily to verify participants' data and to document participants' absences and the reason for the absence. Quick relief medication use will be recorded and measured through the use of a Doser device on participants' inhalers.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 527 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a School Based Hand Sanitizer Program on Asthma
Study Start Date : January 2009
Primary Completion Date : May 2011
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Two Step Hand-Hygiene
Hand washing plus hand sanitizer
Other: Active Hand Sanitizer
Active Hand Sanitizer
Other Name: Purell
No Intervention: Usual Care Hand Hygiene

Outcome Measures

Primary Outcome Measures :
  1. Asthma exacerbations [ Time Frame: Measured at Years 1 and 2 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with asthma
  • Enrolled in a participating elementary school
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528814

United States, Alabama
University of Alabama at Birmingham, Lung Health Center
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI)
Blue Cross Blue Shield
Principal Investigator: William Bailey, MD University of Alabama at Birmingham, Lung Health Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00528814     History of Changes
Other Study ID Numbers: 519
R01HL086972 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Keywords provided by University of Alabama at Birmingham:
Hand Sanitizer
Respiratory Infection

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Hand Sanitizers
Anti-Infective Agents, Local
Anti-Infective Agents